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LMAO!! TRUE THAT!
WOOF,WOOF.TIIIIIMBERRRR!!
Like I said no RMAT are u listening now??!!
U$RM = TIMBER!!!
Read Post#67889 by Hornet Driver. Marvel Trial is just a joke just like Phase I and Phase II trials. Phase III will be more of the same vague and insignificant results.
I hope you are right and your world don't come crashing down if this goes South!!
You are saying stem cells do not have side effects but what about the people that went blind?? What about putting stem cells that differentiate in sites were they are not supposed to be??. I know what you are trying to say but it does not work like that for every action there is a consequence and that consequence could be good or bad.
Yes drugs have side effects too but they have been tested and approved by FDA if that means anything LOL
Stem cell research is still on its infancy or experimental phase. This research is not ready for human clinical trials, it should be done on animal models or people who have a terminal illness. I think its irresponsible for scientists to be trying things they do not fully understand on humans.
Also if you expect a positive RMAT decision will make this stock go into dollar land, think again. There has been a handful of companies that have been approved for RMAT and have not gone up in pps. Those companies do have better value than USRM. Looks like an uphill battle, Don't quit your day job!!
First time I hear Facts and Hard Research Data does not make sense to people. But do not worry the FDA will take this factual research data and use it accordingly. If FDA takes in consideration the data published on the NCBI website for phase I and Phase II which is not only vague but discouraging, I do not see how RMAT will get approved. That's not considering their past incidents by leaving people blind.
USRM WARNING!! Just wanted to present some crude facts about this company before you invest money here.
FACT #1 SDF-1 its an enzyme that recruits stem cells into damage tissue by chemotaxis. Studies show you need at least 300ng to elicit a 25% response in vitro not even in vivo, 300ng is too high concentration to be physiologically relevant and higher doses show diminished response suggesting there is an unknown cofactor involved. Also USRM does not have a GMP facility to come up with this product or the money to contract it out to another Biopharmaceutical company.
PROOF: http://jem.rupress.org/content/185/1/111 ( just see figure 2 )
FACT #2 MYOCELL By the way their patent is a catheter LMAO!! MYOBLASTS are not specific they proliferate into different types of cells they are not specialized cardiopoietic cells. Quote "Bioheart Inc is developing MyoCell, autologous SkMs delivered by MyoCath and MyoStar catheter delivery systems for the treatment of cardiovascular diseases such as myocardial infarction and congestive heart failure."
QUOTE "Toxicity-No specific studies on the toxic nature of SkMs in general and MyoCell in particular have been published so far. In pigs and dogs administered SkMs of approximately 1 × 108 and above, no toxic effects were observed [892764], [920362]."
Clinical development
Phase I
Quote"Patients were followed up for 6 months. At 3 months, angiography but not nuclear or MRI assessment demonstrated a statistically significant increase in LVEF from 36 ± 11 to 41 ± 9%. At 6 months LVEF was increased, but this was not significant. MRI analysis demonstrated significant increase in wall thickening at the injected segments [853498]. Despite it being challenging to derive a firm conclusion, the study results highlighted the feasibility of endovascular cell delivery in the clinic." "INSIGNIFICANT CHANGES"
A second small study was designed to carry out a more in-depth investigation of hemodynamic changes using pressure-volume loop analysis following MyoCell administration [920357]. Patients (n = 5) had an NYHA class greater than 2, reduced LVEF and a previous anterior wall MI. MyoStar injection catheter was used to deliver 15 endocardial injections (apart from in one patient who only received ten injections) each containing approximately 10 × 106 cells. Patients were evaluated at 6 and 12 months using angiography, left ventriculography and right and left heart catheterization. The mean NYHA class was 2.4 ± 0.9, 1.8 ± 0.4 and 2.2 ± 0.4 at baseline, 6 and 12 months; however, none of these differences were significant. There was a significant increase from baseline in cardiac output at 6 and 12 months (from 4.6 ± 0.9 to 5.6 ± 1.6 and 5.4 ± 1.5 l/min, respectively), which was because of non-significant reduced end-systolic volume and increase in heart rate. Ejection fraction was significantly increased at 6 months (from 33 ± 7 to 41 ± 11%) and dP/dtmax was significantly increased at 12 months (from 1025 ± 236 to 1281 ± 328 mmHg/s). The end-systolic pressure-volume relationship was significantly reduced at 6 and 12 months (from 190 ± 95 to 150 ± 107 and 157 ± 75 ml, respectively) [920357]. "AGAIN INSIGNIFICANT CHANGES"
The phase I, multicenter, non-randomized MYOHEART (myogenesis heart efficiency and regeneration trial, NCT00054678) US clinical trial was initiated with a primary objective to evaluate the safety of MyoCell engraftment using MyoCath in patients (n = 20) who had previously experienced MI at least 12 weeks before the initiation of the trial [954669]. Patients were divided into four cohorts of five patients each to receive escalating doses of 25, 75, 225 and 675 × 106 SkM cells with increasing number of injection sites (between 2 and 27). The efficacy endpoints were changes in left ventricular wall thickness and function. There was general but insignificant improvement in LVEF, quality-of-life score and the 6-min walk test. It was observed that the new contractile muscle formed from immature myoblast injections served as a scaffold within the scar tissue [954669]. "THEY EVEN ADMIT THE CHANGES ARE INSIGNIFICANT LMAO"
Phase II
A the SEISMIC trial (NCT00375817) was a phase II, multicenter, randomized, open-label clinical trial sponsored by Bioheart, which was conducted in the US and Europe [744573], [954661]. The trial involved patients (n = 46; 30 MyoCell- and 16 control-treated) with congestive heart failure post-MI and was intended to assess the safety and cardiovascular effects of MyoCell implantation by a catheter delivery system. The primary safety endpoint was defined as serious adverse events at 3 and 6 months, while the secondary safety endpoints were hospitalizations, Holter monitoring, 12-lead ECG data, frequency of ventricular arrhythmias and safety of the use of MyoCath. The primary efficacy endpoint was a change in LVEF and secondary efficacy endpoints were quality-of-life assessment, 6-min walk, NYHA class, and improvements in global contractility, wall thickness, coronary perfusion and infarct size [954661]. Treatment-arm patients were administered 150 to 800 × 106 SkMs cells in 6 to 32 injections using the MyoCath catheter. Over the 6-month period of the trial, 50% of the treatment-arm patients obtained some improvement in LVEF, while 57% of patients in the control group had a worsening of LVEF. Similar to the MYOHEART trial, the newly formed contractile muscle served as a scaffold within the scar tissue. At 6 months, 50% of the treated patients had improvement in NYHA class score compared with 25% of the control group [954661]. WOW! NOT VERY REASSURING!!
Side effects and contraindications
In a pilot clinical trial into the feasibility and safety of MyoCell administration, one out of five patients was hospitalized 6 weeks after treatment because of progressive heart failure and asymptomatic ventricular tachycardia. However, no adverse events were observed in the other patients [853498]. In the other clinical trial of five patients, there were no serious adverse events, however, two patients experienced single episodes of non-sustained ventricular tachycardia [920357].
In one trial of six patients administered 210 ± 150 × 106 SkMs, there were three incidents of ventricular tachycardia in two patients. At 1-year follow-up none of these patients demonstrated repeat ventricular arrhythmia. In addition, three of the control patients experienced ventricular tachycardia during the follow-up period [952338].
During the MYOHEART trial, one out of five patients administered the highest dose died and six patients experienced arrhythmias of which four were thought to be related to the treatment. There was one case of arthralgia, one patient experienced dizziness and one patient suffered a pleural effusion [954669].
During the SEISMIC trial, six patients in the treatment arm experienced a total of 12 significant adverse events, including one death by multiple organ failure, one worsening of heart failure, one pericarditis, ventricular tachycardia in six patients (five of which were thought to be related to the treatment and all were resolved –all patients had experienced ventricular tachycardia prior to the investigation), one hematoma, one herpes zoster and one non-sustained ventricular tachycardia (this also occurred in one patient in the control arm) [954661]. The incidents of arrhythmias were the same in treatment and control groups [954682].
Patent summary
In its 2008 annual filing to the SEC, Bioheart stated that it relies primarily on one US patent for MyoCell, one US patent for its original catheter device MyoCath and a number of patents for its second-generation catheter MyoCath II. The company's “primary MyoCell patent”, US-05130141, was in-licensed in February 2000 from Dr Philip K Law and his company Cell Transplants International. Bioheart says it has no patent protection for MyoCell outside of the US. The initial MyoCath patent, US-05972013, was in-licensed from Comedicus Inc in January 2000. Technology used in MyoCath II was in-licensed from TriCardia LLC in April 2006 (see US-06241710, US-06547769, US-06855132 and US-06949087) [745603].
PROOF!: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668534/
"WHAT a JOKE", REACH YOUR OWN CONCLUSIONS!!
not only will she be confined to a corner she will not be allowed to dance, ever.
This should be a sticky!!! https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668534/
No wonder no RMAT approval what a joke!!
OLD NEWS, none of that will help USRM!!
OLD NEWS, none of that will help USRM!!
Comella not even faithful to USRM she is working for other companies. LMAO!!
I doubt they even want to spend the time to slap us around.They probably anxious for the meeting to be be over and shareholders gone for them to be able to start their party at our expense of course.
because this stock is a ROYAL POS!!
POS should not only be delisted but taken out of existenece!!
U$RM=TIMBER!!!
u can average down when it gets subpenny again!!
who cares if it takes one day or a year this stock is a POS and will get delisted, you missing the point!!
USRM WARNING!! Just wanted to present some crude facts about this company before you invest money here.
FACT #1 SDF-1 its an enzyme that recruits stem cells into damage tissue by chemotaxis. Studies show you need at least 300ng to elicit a 25% response in vitro not even in vivo, 300ng is too high concentration to be physiologically relevant and higher doses show diminished response suggesting there is an unknown cofactor involved. Also USRM does not have a GMP facility to come up with this product or the money to contract it out to another biopharmaceutical company.
PROOF: http://jem.rupress.org/content/185/1/111 ( just see figure 2 )
FACT #2 MYOCELL By the way their patent is a catheter LMAO!! Quote "Bioheart Inc is developing MyoCell, autologous SkMs delivered by MyoCath and MyoStar catheter delivery systems for the treatment of cardiovascular diseases such as myocardial infarction and congestive heart failure."
QUOTE "Toxicity-No specific studies on the toxic nature of SkMs in general and MyoCell in particular have been published so far. In pigs and dogs administered SkMs of approximately 1 × 108 and above, no toxic effects were observed [892764], [920362]."
Clinical development
Phase I
Quote"Patients were followed up for 6 months. At 3 months, angiography but not nuclear or MRI assessment demonstrated a statistically significant increase in LVEF from 36 ± 11 to 41 ± 9%. At 6 months LVEF was increased, but this was not significant. MRI analysis demonstrated significant increase in wall thickening at the injected segments [853498]. Despite it being challenging to derive a firm conclusion, the study results highlighted the feasibility of endovascular cell delivery in the clinic." "INSIGNIFICANT CHANGES"
A second small study was designed to carry out a more in-depth investigation of hemodynamic changes using pressure-volume loop analysis following MyoCell administration [920357]. Patients (n = 5) had an NYHA class greater than 2, reduced LVEF and a previous anterior wall MI. MyoStar injection catheter was used to deliver 15 endocardial injections (apart from in one patient who only received ten injections) each containing approximately 10 × 106 cells. Patients were evaluated at 6 and 12 months using angiography, left ventriculography and right and left heart catheterization. The mean NYHA class was 2.4 ± 0.9, 1.8 ± 0.4 and 2.2 ± 0.4 at baseline, 6 and 12 months; however, none of these differences were significant. There was a significant increase from baseline in cardiac output at 6 and 12 months (from 4.6 ± 0.9 to 5.6 ± 1.6 and 5.4 ± 1.5 l/min, respectively), which was because of non-significant reduced end-systolic volume and increase in heart rate. Ejection fraction was significantly increased at 6 months (from 33 ± 7 to 41 ± 11%) and dP/dtmax was significantly increased at 12 months (from 1025 ± 236 to 1281 ± 328 mmHg/s). The end-systolic pressure-volume relationship was significantly reduced at 6 and 12 months (from 190 ± 95 to 150 ± 107 and 157 ± 75 ml, respectively) [920357]. "AGAIN INSIGNIFICANT CHANGES"
The phase I, multicenter, non-randomized MYOHEART (myogenesis heart efficiency and regeneration trial, NCT00054678) US clinical trial was initiated with a primary objective to evaluate the safety of MyoCell engraftment using MyoCath in patients (n = 20) who had previously experienced MI at least 12 weeks before the initiation of the trial [954669]. Patients were divided into four cohorts of five patients each to receive escalating doses of 25, 75, 225 and 675 × 106 SkM cells with increasing number of injection sites (between 2 and 27). The efficacy endpoints were changes in left ventricular wall thickness and function. There was general but insignificant improvement in LVEF, quality-of-life score and the 6-min walk test. It was observed that the new contractile muscle formed from immature myoblast injections served as a scaffold within the scar tissue [954669]. "THEY EVEN ADMIT THE CHANGES ARE INSIGNIFICANT LMAO"
Phase II
A the SEISMIC trial (NCT00375817) was a phase II, multicenter, randomized, open-label clinical trial sponsored by Bioheart, which was conducted in the US and Europe [744573], [954661]. The trial involved patients (n = 46; 30 MyoCell- and 16 control-treated) with congestive heart failure post-MI and was intended to assess the safety and cardiovascular effects of MyoCell implantation by a catheter delivery system. The primary safety endpoint was defined as serious adverse events at 3 and 6 months, while the secondary safety endpoints were hospitalizations, Holter monitoring, 12-lead ECG data, frequency of ventricular arrhythmias and safety of the use of MyoCath. The primary efficacy endpoint was a change in LVEF and secondary efficacy endpoints were quality-of-life assessment, 6-min walk, NYHA class, and improvements in global contractility, wall thickness, coronary perfusion and infarct size [954661]. Treatment-arm patients were administered 150 to 800 × 106 SkMs cells in 6 to 32 injections using the MyoCath catheter. Over the 6-month period of the trial, 50% of the treatment-arm patients obtained some improvement in LVEF, while 57% of patients in the control group had a worsening of LVEF. Similar to the MYOHEART trial, the newly formed contractile muscle served as a scaffold within the scar tissue. At 6 months, 50% of the treated patients had improvement in NYHA class score compared with 25% of the control group [954661]. WOW! NOT VERY REASSURING!!
Go to:
Side effects and contraindications
In a pilot clinical trial into the feasibility and safety of MyoCell administration, one out of five patients was hospitalized 6 weeks after treatment because of progressive heart failure and asymptomatic ventricular tachycardia. However, no adverse events were observed in the other patients [853498]. In the other clinical trial of five patients, there were no serious adverse events, however, two patients experienced single episodes of non-sustained ventricular tachycardia [920357].
In one trial of six patients administered 210 ± 150 × 106 SkMs, there were three incidents of ventricular tachycardia in two patients. At 1-year follow-up none of these patients demonstrated repeat ventricular arrhythmia. In addition, three of the control patients experienced ventricular tachycardia during the follow-up period [952338].
During the MYOHEART trial, one out of five patients administered the highest dose died and six patients experienced arrhythmias of which four were thought to be related to the treatment. There was one case of arthralgia, one patient experienced dizziness and one patient suffered a pleural effusion [954669].
During the SEISMIC trial, six patients in the treatment arm experienced a total of 12 significant adverse events, including one death by multiple organ failure, one worsening of heart failure, one pericarditis, ventricular tachycardia in six patients (five of which were thought to be related to the treatment and all were resolved –all patients had experienced ventricular tachycardia prior to the investigation), one hematoma, one herpes zoster and one non-sustained ventricular tachycardia (this also occurred in one patient in the control arm) [954661]. The incidents of arrhythmias were the same in treatment and control groups [954682].
Patent summary
In its 2008 annual filing to the SEC, Bioheart stated that it relies primarily on one US patent for MyoCell, one US patent for its original catheter device MyoCath and a number of patents for its second-generation catheter MyoCath II. The company's “primary MyoCell patent”, US-05130141, was in-licensed in February 2000 from Dr Philip K Law and his company Cell Transplants International. Bioheart says it has no patent protection for MyoCell outside of the US. The initial MyoCath patent, US-05972013, was in-licensed from Comedicus Inc in January 2000. Technology used in MyoCath II was in-licensed from TriCardia LLC in April 2006 (see US-06241710, US-06547769, US-06855132 and US-06949087) [745603].
PROOF!: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668534/
"WHAT a JOKE", REACH YOUR OWN CONCLUSIONS!!
USRM WARNING!! Just wanted to present some crude facts about this company before you invest money here.
FACT #1 SDF-1 its an enzyme that recruits stem cells into damage tissue by chemotaxis. Studies show you need at least 300ng to elicit a 25% response in vitro not even in vivo, 300ng is too high concentration to be physiologically relevant and higher doses show diminished response suggesting there is an unknown cofactor involved. Also USRM does not have a GMP facility to come up with this product or the money to contract it out to another Biopharmaceutical company.
PROOF: http://jem.rupress.org/content/185/1/111 ( just see figure 2 )
FACT #2 MYOCELL By the way their patent is a catheter LMAO!! Quote "Bioheart Inc is developing MyoCell, autologous SkMs delivered by MyoCath and MyoStar catheter delivery systems for the treatment of cardiovascular diseases such as myocardial infarction and congestive heart failure."
QUOTE "Toxicity-No specific studies on the toxic nature of SkMs in general and MyoCell in particular have been published so far. In pigs and dogs administered SkMs of approximately 1 × 108 and above, no toxic effects were observed [892764], [920362]."
Clinical development
Phase I
Quote"Patients were followed up for 6 months. At 3 months, angiography but not nuclear or MRI assessment demonstrated a statistically significant increase in LVEF from 36 ± 11 to 41 ± 9%. At 6 months LVEF was increased, but this was not significant. MRI analysis demonstrated significant increase in wall thickening at the injected segments [853498]. Despite it being challenging to derive a firm conclusion, the study results highlighted the feasibility of endovascular cell delivery in the clinic." "INSIGNIFICANT CHANGES"
A second small study was designed to carry out a more in-depth investigation of hemodynamic changes using pressure-volume loop analysis following MyoCell administration [920357]. Patients (n = 5) had an NYHA class greater than 2, reduced LVEF and a previous anterior wall MI. MyoStar injection catheter was used to deliver 15 endocardial injections (apart from in one patient who only received ten injections) each containing approximately 10 × 106 cells. Patients were evaluated at 6 and 12 months using angiography, left ventriculography and right and left heart catheterization. The mean NYHA class was 2.4 ± 0.9, 1.8 ± 0.4 and 2.2 ± 0.4 at baseline, 6 and 12 months; however, none of these differences were significant. There was a significant increase from baseline in cardiac output at 6 and 12 months (from 4.6 ± 0.9 to 5.6 ± 1.6 and 5.4 ± 1.5 l/min, respectively), which was because of non-significant reduced end-systolic volume and increase in heart rate. Ejection fraction was significantly increased at 6 months (from 33 ± 7 to 41 ± 11%) and dP/dtmax was significantly increased at 12 months (from 1025 ± 236 to 1281 ± 328 mmHg/s). The end-systolic pressure-volume relationship was significantly reduced at 6 and 12 months (from 190 ± 95 to 150 ± 107 and 157 ± 75 ml, respectively) [920357]. "AGAIN INSIGNIFICANT CHANGES"
The phase I, multicenter, non-randomized MYOHEART (myogenesis heart efficiency and regeneration trial, NCT00054678) US clinical trial was initiated with a primary objective to evaluate the safety of MyoCell engraftment using MyoCath in patients (n = 20) who had previously experienced MI at least 12 weeks before the initiation of the trial [954669]. Patients were divided into four cohorts of five patients each to receive escalating doses of 25, 75, 225 and 675 × 106 SkM cells with increasing number of injection sites (between 2 and 27). The efficacy endpoints were changes in left ventricular wall thickness and function. There was general but insignificant improvement in LVEF, quality-of-life score and the 6-min walk test. It was observed that the new contractile muscle formed from immature myoblast injections served as a scaffold within the scar tissue [954669]. "THEY EVEN ADMIT THE CHANGES ARE INSIGNIFICANT LMAO"
Phase II
A the SEISMIC trial (NCT00375817) was a phase II, multicenter, randomized, open-label clinical trial sponsored by Bioheart, which was conducted in the US and Europe [744573], [954661]. The trial involved patients (n = 46; 30 MyoCell- and 16 control-treated) with congestive heart failure post-MI and was intended to assess the safety and cardiovascular effects of MyoCell implantation by a catheter delivery system. The primary safety endpoint was defined as serious adverse events at 3 and 6 months, while the secondary safety endpoints were hospitalizations, Holter monitoring, 12-lead ECG data, frequency of ventricular arrhythmias and safety of the use of MyoCath. The primary efficacy endpoint was a change in LVEF and secondary efficacy endpoints were quality-of-life assessment, 6-min walk, NYHA class, and improvements in global contractility, wall thickness, coronary perfusion and infarct size [954661]. Treatment-arm patients were administered 150 to 800 × 106 SkMs cells in 6 to 32 injections using the MyoCath catheter. Over the 6-month period of the trial, 50% of the treatment-arm patients obtained some improvement in LVEF, while 57% of patients in the control group had a worsening of LVEF. Similar to the MYOHEART trial, the newly formed contractile muscle served as a scaffold within the scar tissue. At 6 months, 50% of the treated patients had improvement in NYHA class score compared with 25% of the control group [954661]. WOW! NOT VERY REASSURING!!
Side effects and contraindications
In a pilot clinical trial into the feasibility and safety of MyoCell administration, one out of five patients was hospitalized 6 weeks after treatment because of progressive heart failure and asymptomatic ventricular tachycardia. However, no adverse events were observed in the other patients [853498]. In the other clinical trial of five patients, there were no serious adverse events, however, two patients experienced single episodes of non-sustained ventricular tachycardia [920357].
In one trial of six patients administered 210 ± 150 × 106 SkMs, there were three incidents of ventricular tachycardia in two patients. At 1-year follow-up none of these patients demonstrated repeat ventricular arrhythmia. In addition, three of the control patients experienced ventricular tachycardia during the follow-up period [952338].
During the MYOHEART trial, one out of five patients administered the highest dose died and six patients experienced arrhythmias of which four were thought to be related to the treatment. There was one case of arthralgia, one patient experienced dizziness and one patient suffered a pleural effusion [954669].
During the SEISMIC trial, six patients in the treatment arm experienced a total of 12 significant adverse events, including one death by multiple organ failure, one worsening of heart failure, one pericarditis, ventricular tachycardia in six patients (five of which were thought to be related to the treatment and all were resolved –all patients had experienced ventricular tachycardia prior to the investigation), one hematoma, one herpes zoster and one non-sustained ventricular tachycardia (this also occurred in one patient in the control arm) [954661]. The incidents of arrhythmias were the same in treatment and control groups [954682].
Patent summary
In its 2008 annual filing to the SEC, Bioheart stated that it relies primarily on one US patent for MyoCell, one US patent for its original catheter device MyoCath and a number of patents for its second-generation catheter MyoCath II. The company's “primary MyoCell patent”, US-05130141, was in-licensed in February 2000 from Dr Philip K Law and his company Cell Transplants International. Bioheart says it has no patent protection for MyoCell outside of the US. The initial MyoCath patent, US-05972013, was in-licensed from Comedicus Inc in January 2000. Technology used in MyoCath II was in-licensed from TriCardia LLC in April 2006 (see US-06241710, US-06547769, US-06855132 and US-06949087) [745603].
PROOF!: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668534/
"WHAT a JOKE", REACH YOUR OWN CONCLUSIONS!!
your entitled to opinion i just posted FACTS!!
USRM WARNING!! Just wanted to present some crude facts about this company before you invest money here.
FACT #1 SDF-1 its an enzyme that recruits stem cells into damage tissue by chemotaxis. Studies show you need at least 300ng to elicit a 25% response in vitro not even in vivo. 300ng is too high concentration to be physiologically relevant and higher doses show diminished response suggesting there is an unknown cofactor involved. Also USRM does not have a GMP facility to come up with this product or the money to contracted out to another biopharmaceutical company.
PROOF: http://jem.rupress.org/content/185/1/111 ( just see figure 2 )
FACT #2 MYOCELL Their patent is a catheter LMAO!! Quote "Bioheart Inc is developing MyoCell, autologous SkMs delivered by MyoCath and MyoStar catheter delivery systems for the treatment of cardiovascular diseases such as myocardial infarction and congestive heart failure."
QUOTE "Toxicity-No specific studies on the toxic nature of SkMs in general and MyoCell in particular have been published so far. In pigs and dogs administered SkMs of approximately 1 × 108 and above, no toxic effects were observed [892764], [920362]."
Clinical development
Phase I
Quote"Patients were followed up for 6 months. At 3 months, angiography but not nuclear or MRI assessment demonstrated a statistically significant increase in LVEF from 36 ± 11 to 41 ± 9%. At 6 months LVEF was increased, but this was not significant. MRI analysis demonstrated significant increase in wall thickening at the injected segments [853498]. Despite it being challenging to derive a firm conclusion, the study results highlighted the feasibility of endovascular cell delivery in the clinic." "INSIGNIFICANT CHANGES"
A second small study was designed to carry out a more in-depth investigation of hemodynamic changes using pressure-volume loop analysis following MyoCell administration [920357]. Patients (n = 5) had an NYHA class greater than 2, reduced LVEF and a previous anterior wall MI. MyoStar injection catheter was used to deliver 15 endocardial injections (apart from in one patient who only received ten injections) each containing approximately 10 × 106 cells. Patients were evaluated at 6 and 12 months using angiography, left ventriculography and right and left heart catheterization. The mean NYHA class was 2.4 ± 0.9, 1.8 ± 0.4 and 2.2 ± 0.4 at baseline, 6 and 12 months; however, none of these differences were significant. There was a significant increase from baseline in cardiac output at 6 and 12 months (from 4.6 ± 0.9 to 5.6 ± 1.6 and 5.4 ± 1.5 l/min, respectively), which was because of non-significant reduced end-systolic volume and increase in heart rate. Ejection fraction was significantly increased at 6 months (from 33 ± 7 to 41 ± 11%) and dP/dtmax was significantly increased at 12 months (from 1025 ± 236 to 1281 ± 328 mmHg/s). The end-systolic pressure-volume relationship was significantly reduced at 6 and 12 months (from 190 ± 95 to 150 ± 107 and 157 ± 75 ml, respectively) [920357]. "AGAIN INSIGNIFICANT CHANGES"
The phase I, multicenter, non-randomized MYOHEART (myogenesis heart efficiency and regeneration trial, NCT00054678) US clinical trial was initiated with a primary objective to evaluate the safety of MyoCell engraftment using MyoCath in patients (n = 20) who had previously experienced MI at least 12 weeks before the initiation of the trial [954669]. Patients were divided into four cohorts of five patients each to receive escalating doses of 25, 75, 225 and 675 × 106 SkM cells with increasing number of injection sites (between 2 and 27). The efficacy endpoints were changes in left ventricular wall thickness and function. There was general but insignificant improvement in LVEF, quality-of-life score and the 6-min walk test. It was observed that the new contractile muscle formed from immature myoblast injections served as a scaffold within the scar tissue [954669]. "THEY EVEN ADMIT THE CHANGES ARE INSIGNIFICANT LMAO"
Phase II
A the SEISMIC trial (NCT00375817) was a phase II, multicenter, randomized, open-label clinical trial sponsored by Bioheart, which was conducted in the US and Europe [744573], [954661]. The trial involved patients (n = 46; 30 MyoCell- and 16 control-treated) with congestive heart failure post-MI and was intended to assess the safety and cardiovascular effects of MyoCell implantation by a catheter delivery system. The primary safety endpoint was defined as serious adverse events at 3 and 6 months, while the secondary safety endpoints were hospitalizations, Holter monitoring, 12-lead ECG data, frequency of ventricular arrhythmias and safety of the use of MyoCath. The primary efficacy endpoint was a change in LVEF and secondary efficacy endpoints were quality-of-life assessment, 6-min walk, NYHA class, and improvements in global contractility, wall thickness, coronary perfusion and infarct size [954661]. Treatment-arm patients were administered 150 to 800 × 106 SkMs cells in 6 to 32 injections using the MyoCath catheter. Over the 6-month period of the trial, 50% of the treatment-arm patients obtained some improvement in LVEF, while 57% of patients in the control group had a worsening of LVEF. Similar to the MYOHEART trial, the newly formed contractile muscle served as a scaffold within the scar tissue. At 6 months, 50% of the treated patients had improvement in NYHA class score compared with 25% of the control group [954661]. WOW! NOT VERY REASSURING!!
Go to:
Side effects and contraindications
In a pilot clinical trial into the feasibility and safety of MyoCell administration, one out of five patients was hospitalized 6 weeks after treatment because of progressive heart failure and asymptomatic ventricular tachycardia. However, no adverse events were observed in the other patients [853498]. In the other clinical trial of five patients, there were no serious adverse events, however, two patients experienced single episodes of non-sustained ventricular tachycardia [920357].
In one trial of six patients administered 210 ± 150 × 106 SkMs, there were three incidents of ventricular tachycardia in two patients. At 1-year follow-up none of these patients demonstrated repeat ventricular arrhythmia. In addition, three of the control patients experienced ventricular tachycardia during the follow-up period [952338].
During the MYOHEART trial, one out of five patients administered the highest dose died and six patients experienced arrhythmias of which four were thought to be related to the treatment. There was one case of arthralgia, one patient experienced dizziness and one patient suffered a pleural effusion [954669].
During the SEISMIC trial, six patients in the treatment arm experienced a total of 12 significant adverse events, including one death by multiple organ failure, one worsening of heart failure, one pericarditis, ventricular tachycardia in six patients (five of which were thought to be related to the treatment and all were resolved –all patients had experienced ventricular tachycardia prior to the investigation), one hematoma, one herpes zoster and one non-sustained ventricular tachycardia (this also occurred in one patient in the control arm) [954661]. The incidents of arrhythmias were the same in treatment and control groups [954682].
Patent summary
In its 2008 annual filing to the SEC, Bioheart stated that it relies primarily on one US patent for MyoCell, one US patent for its original catheter device MyoCath and a number of patents for its second-generation catheter MyoCath II. The company's “primary MyoCell patent”, US-05130141, was in-licensed in February 2000 from Dr Philip K Law and his company Cell Transplants International. Bioheart says it has no patent protection for MyoCell outside of the US. The initial MyoCath patent, US-05972013, was in-licensed from Comedicus Inc in January 2000. Technology used in MyoCath II was in-licensed from TriCardia LLC in April 2006 (see US-06241710, US-06547769, US-06855132 and US-06949087) [745603].
PROOF!: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668534/
"WHAT a JOKE", REACH YOUR OWN CONCLUSIONS!!
One can ignore the facts but that does not mean they are not there!!
Oh MY GOD!! How could I have missed this. I hate being right, as suspected Myocell is crappola just like SDF-1. First Myocell is not a product is a procedure LOL, No company is gonna buy a procedure LMAO!! And I finally understand what the patent is all about. I knew they cannot patent a procedure anyone can do this procedure. If anyone has the rights of stem cell therapy royalties it would be the Wisconsin Alumni Research Foundation and invented by James Thomson but they do not enforce it at least not yet. Look it up here, https://en.wikipedia.org/wiki/Stem_cell
What they have is a patent for a catheter they used to administer the stem cells LMFAO!!
Now the cherry on top. All clinical trials or so they say Oh MY GOD there is no data could they have been more vague and WOW!! at 6 weeks 50% of the candidates show showed improvement at Phase II. Are you serious what a joke. Read all about it here, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668534/
Im taking my $700 investment out tomorrow.
This should be a sticky!! I need to post this article every day.
Could you show us what DD did you used to assume a future buyout? or just a simple logical explanation as to why you think that. I cannot find any particular reason why a company would buy USRM. Could you at least post any hard data on studies done on SDF-1 or myocell. Please share do not keep it to yourself.
http://jem.rupress.org/content/185/1/111 Look at figure 2 SDF-1 is crappola and I bet myocell is too. The only serious life changing event is adipo stem cell but that procedure can be done by anyone. My bet is some will do the job better than others but with USRM track record I rather have the procedure done with someone else.
Having so many stem cell companies out there what is it so magical about this company that others might want? Do you even know this myocell or SDF-1 actually works?, have you seen the hard data or you just hoping is good. LMAO!!
Funny how most claim upside and the possibility of multidollar highs on nothing just based on RMAT approval. No possibility of downside LMAO. Its called pumping a stock!!
https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/enforcementactivitiesbyfda/selectedenforcementactionsonunapproveddrugs/ucm238675.htm
Do you have any idea how many drugs have actually been denied by FDA. A lot more than they have approved. USRM might be next on their list.
Tell that to the 3 woman who lost their eyesight or to the FDA see what they say.
IRRELEVANT!! that's not how a company should do business. The victims could still see before treatment now they are Blind. In my opinion that was reckless and FDA knows that.
http://www.npr.org/sections/health-shots/2017/03/15/520118310/3-women-blinded-by-unproven-stem-cell-treatments
This is what happens when a company does not have a good grasp on what they are doing. I bet FDA will be very cautious in giving this guys RMAT approval.
I'm sorry but legit companies do NOT use clandestine settings and leave people blind. Then settle lawsuit in the background. Change company names and hope that never did happen.
What will u do when RMAT is denied?I'll tell you people gonna freak out and sell.STAMPEDE!!!!
TIMBER!!!
He took a few steps back and now he is able to see the forest not just the trees. And the forest is saying get the heck out of here.
I have been asking that same question for a long time but noone answers