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I guess what I had thought rumit is that I had confirmed this very topic on the MA09 line with either Lanza or Caldwell and that is why I posted this link time and time again.
http://umassmed.edu/uploadedFiles/umscr/Human%20Embryonic%20Stem%20Cell%20lines%20established%20at%20ACT.pdf
Apparently I didn't, senility maybe?..:)
rumit,
I really have no doubts myself but was looking for an official confirm from CSO or CEO. It is a topic I get questioned on via mail almost weekly. I was pretty sure I had confirmed with Mr. Caldwell last year but I don't find it in my files or on this board so I am trying to do so for the record...thanks rumit
louisa,
I first posted it here about 15 months ago or so and it has been discussed quite often. With all that takes place it is very easy to overlook items as I have done many times also.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46769530
thanks cty, so far the sites seem to be following the November Executive summary somewhat. Note Jules Stein was only one listed for both trials and probably indicated lead clinic(I missed that) and now Casey coming in under Stargardts. I had figured Casey for the lead but had no doubt about their participation.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=62263635
Filed IND for treatment of Stargardt’s disease ? IND was approved by FDA on 19 November 2010. ? IRB has approved protocol - Anticipate commencing patient treatment in 1Q2011. ? Designated trial sites: Jules Stein Eye Institute (UCLA); Casey Eye Institute (Oregon Health Sciences University); University of Massachusetts Memorial Medical Center; New Jersey Medical School.
? Filed IND for treatment of Dry AMD on 26 November 2010 ? Anticipate FDA approval and first patient treatment in second half of 2011. ? Designated trial sites: Jules Stein Eye Institute (UCLA); Stanford University School of Medicine; and the Edward S. Harness Eye Institute (Columbia University College of Physicians and Surgeons).
http://www.advancedcell.com/documents/Executive_Summary-ACT_RPE_Program.pdf
Spetty,
others have done so already according to my mail. Keep in mind both trials are using MA09-hRPE cell line, not the NED(non embryo destruction) lines. MA09 line was obtained by the "Single blastomere-derived hES cell lines (embryos not preserved)"
http://umassmed.edu/uploadedFiles/umscr/Human%20Embryonic%20Stem%20Cell%20lines%20established%20at%20ACT.pdf
I will work on confirming this but it's how I read it at this time.
A couple patent applications close to Patent approval as well as other info:
In addition to the patent application "close to approval" Patent Application # 11/787,262, posted by Capt_Smith..
HUMAN HEMANGIO-COLONY FORMING CELLS
Here is another ACT application ready to be patented.
United States Patent & Trademark Office
application number 10/374,512
GYNOGENETIC OR ANDROGENETIC PRODUCTION OF PLURIPOTENT CELLS AND CELL LINES, AND USE THEREOF TO PRODUCE DIFFERENTIATED CELLS AND TISSUES
Patent Issue Date Used in PTA Calculation 5-31-2011
___________________________________________________________________
ACT Patents Issued and Patent Applications in past 12 months
These 4 are well known Patents and can be found on slide 22 of latest conference presentation.
http://www.advancedcell.com/document...gress_2011.pdf
Patents Received in Last Year
#7794704
METHODS FOR PRODUCING ENRICHED POPULATIONS OF HUMAN RETINAL PIGMENT EPITHELIUM CELLS FOR TREATMENT OF RETINAL DEGENERATION
#7736896
METHODS FOR PRODUCING ENRICHED POPULATIONS OF HUMAN RETINAL PIGMENT EPITHELIUM CELLS
#7795025
METHODS FOR PRODUCING ENRICHED POPULATIONS OF HUMAN RETINAL PIGMENT EPITHELIUM CELLS
#7893315
DERIVATION OF EMBRYONIC STEM CELLS AND EMBRYO-DERIVED CELLS
Here are 3 more Patents issued in past year with one a couple months ago
#7794704..Issued 4-13-2010
EMBRYONIC OR STEM-LIKE CELL LINES PRODUCED BY CROSS SPECIES NUCLEAR TRANSPLANTATION AND METHODS FOR ENHANCING EMBRYONIC DEVELOPMENT BY GENETIC ALTERATION OF DONOR CELLS OR BY TISSUE CULTURE CONDITIONS
#7838727..Issued 11-23-2010
DERIVATION OF EMBRYONIC STEM CELLS
#7910369..Issued 3-22-2011
NOVEL CULTURE SYSTEMS FOR EX VIVO DEVELOPMENT
Patent Applications in Past Year
#12528212..published 09/23/2010
HIGHLY EFFICIENT METHODS FOR REPROGRAMMING DIFFERENTIATED CELLS AND FOR GENERATING ANIMALS AND EMBRYONIC STEM CELLS FROM REPROGRAMMED CELLS
#12809704..published 02/03/2011
Methods Of Producing Pluripotent Stem Cell-Generated Embryos, And Animals Derived There from
#12991096..published 03/17/2011
HEMANGIO COLONY FORMING CELLS AND NON-ENGRAFTING HEMANGIO CELLS
#12991111..published 04/14/2011
METHODS FOR PRODUCING ENUCLEATED ERYTHROID CELLS DERIVED FROM PLURIPOTENT STEM CELLS
The United States Patent and Trademark Office Patent Assignee Summary site can be a valuable source of info for tracking patents and applications, new or older. This site was my source for all above info using page 2 and 3 from following link.
http://assignments.uspto.gov/assignments/q?db=pat&asne=ADVANCED%20CELL%20TECHNOLOGY&page=1
Spetty,
It is a distinct possibly and probably not a surprise as indicated by ACT last November.
"Filed IND for treatment of Dry AMD on 26 November 2010 ? Anticipate FDA approval and first patient treatment in second half of 2011. ? Designated trial sites: Jules Stein Eye Institute (UCLA); Stanford University School of Medicine; and the Edward S. Harness Eye Institute (Columbia University College of Physicians and Surgeons)."
http://www.advancedcell.com/documents/Executive_Summary-ACT_RPE_Program.pdf
yep,
"CHA Biotech expanded its operations to the United States in 2002 with the opening of CHA Fertility Center in Los Angeles followed by the 2005 acquisition of Hollywood Presbyterian Medical Center, a 434-bed general, acute-care hospital also located in LA."
http://www.advancedcell.com/news-and-media/press-releases/joint-venture-between-cha-biotech-and-advanced-cell-technology-to-be-called-stem-cell-and-regenerativ/
louisa,
posted by ABR may be as good as any,
"If you are wondering why this is being held in Palm Springs, California instead of near Marlborough, MA - all three of the folks on the Board of Directors (Gary Rabin, Erkki Ruoslahti, and Alan Shapiro) live in California, in or near the Los Angeles area. Palm Springs is about 100 miles east of Los Angeles."
http://investorstemcell.com/forum/advanced-cell-technology/1821.htm
Shareholder Meeting,
For those asking, NO I will not be attending the SHM and Proposals 3 and 4 don't mean a whole lot as noted below. The Compenation Committee will decide on such things as Rabin's performance bonus based on metrics unstated. Caldwell's performance bonus was based on a stated pps chart which didn't pan out so well and probably why Rabin's is unstated.
(from 10K)
"The Company shall pay Mr. Rabin a performance bonus. The target amount of the performance bonus shall be $480,000 (i.e., 100% of Base Salary) per year. However, the performance bonus shall be no less than $144,000 (i.e., 30% of Base Salary) per year and no more than $720,000 (i.e., 150% of Base Salary) per year. The actual amount of the performance bonus shall be determined by the Compensation Committee of the Board during each calendar year quarter based on the performance of the Company and Mr. Rabin, with reference to the performance goals and/or metrics established by the Compensation Committee in consultation with Mr. Rabin with respect to such performance bonus period."
((proposals 3 & 4)
"Because your vote is advisory, it will not be binding on either the Board of Directors or the Company. However, the Company’s Compensation Committee will take into account the outcome of the stockholder vote on this proposal at the Annual Meeting when considering future executive compensation arrangements. In addition, your non-binding advisory votes described in this Proposal 3 and below in Proposal 4 will not be construed: (1) as overruling any decision by the Board of Directors, any Board committee or the Company relating to the compensation of the named executive officers, or (2) as creating or changing any fiduciary duties or other duties on the part of the Board of Directors, any Board committee or the Company."
http://www.sec.gov/Archives/edgar/data/1140098/000114420411027813/v221776_def14a.htm
hopefulstem,
For those mailing questions about time frames for possible trial results, here is a response from CEO on topic.
Posted by ACTC_Fan at InvestorStemCell
Clarification from Gary about timing of trial data being released
I emailed Gary requesting some clarification on the timing of trial data being released and received the below response. (along with his permission to publish the response here) Very nice of him to take the time out to clarify this, much appreciated. Thanks to abr for providing me his email.
______________________________
Hello *****,
Thanks for your questions. The Phase 1 trial endpoints are, by definition, safety endpoints (e.g., no teratomas, no ectopic tissue, no severe retinal damage, no immune rejection issues, etc.). However, because of the nature of the auto-fluorescence and OCT imaging we can do, we hope to be able to demonstrate the kind of engraftment that we have seen in our animal models (see slide 14 from my discussion). Certainly, the patient selection of the first cohorts in the trials, particularly of the AMD patients (who will tend to be elderly with severely deteriorated sight) may impact our engraftment viability. For this reason, the early results should not be viewed as a clear window into the ultimate efficacy of the study, but we want to provide as much transparency as possible to the investors into our results.
We plan to release patient data after the first three patients in each trial have had at least 6-8 weeks of post-injection experience (so roughly 3-3.5 months after first patient treatment).
I hope this answers you.
Best,
Gary
_____________________
http://investorstemcell.com/forum/advanced-cell-technology/1855.htm
Wondering about the other two guys...did not read the whole thing. Vincent and ????. Will they stay on?
Only relates to BOD's
So much for getting new BOD's as Rabin had suggested. Yep, same members on the Compensation Committee who then must be approved by the BOD's who are the same 3 people...Salary is peanuts compared to the 5 million shares they each gave themselves last year..
PRE 14A filed,
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS
TO BE HELD ON JUNE 9, 2011
To our Stockholders:
The 2011Annual Meeting of Stockholders (the “Annual Meeting”) of Advanced Cell Technology, Inc. (“Advanced Cell” or the “Company”) will be held at the Hyatt Regency Suites, Palm Springs, 285 N. Palm Canyon Dr., Palm Springs, CA 92262, on Thursday, June 9, 2011, at 9:00 am local time, to consider the following proposals:
1. To elect the three (3) persons named herein as nominees for directors of the Company, to hold office until the next annual meeting of stockholders and until their respective successors have been duly elected and qualified (Proposal No. 1);
2. To ratify the appointment of SingerLewak LLP as the Company’s independent registered accounting firm for the fiscal year ending December 31, 2011 (Proposal No. 2);
3. To conduct an advisory vote on executive compensation (Proposal No. 3);
4. To conduct an advisory vote on the frequency of future advisory votes on executive compensation (Proposal No. 4); and
5. To act on such other matters as may properly come before the meeting or any adjournment or adjournments thereof.
http://www.sec.gov/Archives/edgar/data/1140098/000114420411027813/v221776_def14a.htm
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No, and there really doesn't seem to be any pattern with the European Commission. Below is an article that suggests the same.
http://www.simplypennies.com/2011/03/actc-positive-opinion-by-comp-starts-new-waiting-game/
EU Orphan Designation,
Poster on Icell indicated the COMP meeting will NOT approve Orphan desig, rather the European Commission will. I did some digging and the following shows he is right. Thanks JHam for bringing it to light.
To benefit from the incentives, sponsors intending to develop an orphan medicine must submit an application to the Agency requesting 'orphan designation' for their medicine. The application is evaluated by the Agency's Committee for Orphan Medicinal Products (COMP), which provides its opinion on whether or not the medicine qualifies as an orphan medicine for the treatment, prevention or diagnosis of a rare disease. If the COMP issues a positive opinion, the European Commission may then grant the medicine orphan status.European Medicines Agency
http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000034.jsp&murl=menus/special_topics/special_topics.jsp&mid=WC0b01ac058002d4eb&jsenabled=false
5. If a medicinal product has already been granted orphan drug designation in the US or Japan, would this be automatically accepted for the EU?
No, the EU Regulation does not foresee recognition of orphan status granted in other regions. In addition, the criteria for orphan designation are not internationally harmonised. Orphan designation can only be granted in the EU, by the European Commission, once an application for designation has been reviewed by the Committee for Orphan Medicinal Products, in accordance with the procedure laid down in Article 5, Regulation (EC) 141/2000 of 16 December 1999.
http://www.ema.europa.eu/docs/en_GB/...C500003967.pdf
(COMP Positive opinion received 8-9 March 2011)
Human embryonic stem-cell-derived retinal pigment epithelial cells for treatment of Stargardt’s disease; TMC Pharma Services Ltd.
http://www.ema.europa.eu/docs/en_GB/...C500102965.pdf
several mail topic ?'s,
Will EU Orphan Desig. get approved soon?
Yes, I would expect and see no reason this designation won't be approved at meeting now ongoing provided whatever issues that are on the table are resolved. Link to COMP meeting
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2010/06/event_detail_000288.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c3&jsenabled=true
Will the EU court ruling in March have any bearing on Orphan Desig?
It is very possible if the ruling isn't changed that it could have a big impact on hESC patents, trials and commercialization. Until the ruling is ironed out in some fashion, I wouldn't expect any current decisions on Orphan status or CTA's to be impacted, jmo.
If you are not familiar with ruling this article provides the gist of it, posted by CTY
"In Europe, regulations regarding embryonic stem-cell research differ from country to country. However, a ruling on Mar. 10, 2011, by the European Court of Justice of the European Communities denied patents on ES cells to Oliver Brüstle of the University of Bonn on ethical grounds. The court found that even if cell lines could be established without the destruction of embryos, the commercialization of human embryos was unacceptable, and contrary to public policy. This ruling may push European countries to adopt restrictive policies regarding embryonic stem cells and inhibit the development of ES-based therapies."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=61552950
Rock, is ACT putting all their eggs in one basket with all the same RPE trials?"
If everything "goes as planned" with 2 US trials and possibly the 3rd in EU somewhere (and CHA in Korea) it opens up a tremendous market in a relatively short time. On the other hand, a setback with one could possibly affect all of them. It is what it is, if I had a preference or a say in the matter I would opt for the 2US trials of RPE and Phase 2 of Myoblast starting in the much less controversial adult stem cell arena, again, jmo.
"rocky301, does the OS# and all that still concern you?"
Absolutely. Without hesitation I believe it is the major reason we are trading below .20. Float approx. 1.5B on the OTC is huge and imo we will not grow the pps to levels needed to meet bid requirements on a big board exchange. As mentioned prior regarding rs, Mr. Rabin has stated "he doesn't want to alienate shareholders". I understand the logic and appreciate that but also believe we are at a point with trials and endpoint results where ACT is alienating the instituional money and all the perks and exposure that come with a large exchange..again, this is opinion.
Something should be out in print soon as to the outcome of ongoing meeting,
(slide 2)at bottom
Upcoming meetings
The 123rd meeting of the COMP will be held on 4-5 May 2011.
http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2011/04/WC500105111.pdf
Twaro,
10Q due May 10. For me, relevant info is OS#, diluted OS# warrants/options exercised, cash on hand etc; Other than that, a person never knows what may be in there..
RABIN Quote from CC,
Estimated Enrollment: 12
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
http://clinicaltrials.gov/ct2/results?term=%22Advanced+Cell+Technology%22
rumit,
I had several e-mails out on whether ACT applied for RFA 10-03. Another just came in.
Our longstanding policy is that we only divulge the names of applicants that have gone all the way through the review process and were successful. We only had one applicant that went all the way through the review process for RFA 10-03.
Don Gibbons
Chief Communications Officer
California Institute for Regenerative Medicine
The State Stem Cell Agency‹
210 King Street
San Francisco, CA 94107
415-396-9117
On 5/2/11 1:24 PM, "Rocky" <rocky301@charter.net> wrote:
Hello, Can you please tell me if Advanced Cell Technology has applied or better yet point to me a review of their application. I only see one review for RF 10-03 and that is GERON.
Summary of application CT1-05168 | California Institute for Regenerative Medicine
Any help at all appreciated..thank you
UPDATE CIRM: RABIN RESPONSE
It seemed a natural and obvious fit that the CIRM 10-03(funding for clinical trials) would have been where ACT applied. I spent time on this yesterday and found no evidence that we applied or were in the hunt for this RFA with a meeting set for tomorrow on this funding. I went to the source and have the e-mail posted below with permission to repost here.
RFA 10-03: CIRM TARGETED CLINICAL DEVELOPMENT AWARDS
http://www.cirm.ca.gov/files/grants/...nded.10.15.pdf
__________________________________________________
From: Rocky [mailto:rocky301@charter.net]
Sent: Tuesday, May 03, 2011 10:56 AM
To: Gary Rabin
Subject: CIRM
Mr. Rabin,
In the March CC you mentioned CIRM and application of about $4MM.
I was assuming the application would be under the following:
RFA 10-03: CIRM Targeted Clinical Development Awards
Tomorrow a meeting is being held with this being part of agenda,
8. Consideration of recommendations from Grants Working Group regarding applications submitted in response to RFA 10-03: CIRM Targeted Clinical Development Awards
The only recommendation on CIRM site is the following which is GERON for just under $25MM
Summary of application CT1-05168 | California Institute for Regenerative Medicine
Is the RFA 10-03 where ACT applied? or was it under some other funding opportunity?
Thanks for any help/guidance on this issue...
Rock
Hi Rocky,
The CIRM funding RFA that we are interested in has an October deadline. Apologize for any confusion. The October round is the corporate funding RFA that carries with it the set of restrictions that would be palatable to our clinical partners. Can't fit a square peg in a round hole....
Nice to hear from you. We are so busy getting ready for trials and all of the other corporate activities.
Best,
Gary
rumit,
somewhat informative transcript of CIRM meeting last March on the RFA 10-03 if you haven't already see it. Start around slide 41
http://cirm.ca.gov/files/meetings/pdf/2010/ICOC-3-11-10.pdf
That is included under the $9-$10MM operating costs..eom
Once again, it is for a Research Facility and NOT "UCLA is getting grant for the RPE trial:" BTW, your ACT blurb is on page 25..
what slide in the document made you think that? Not 85 I hope..How about a RESEARCH FACILITIES GRANT?
rumit,
whether loans or grants the more the better. Between the projected $9-$10MM in operating costs plus the projected $5-$7MM for both Phase 1 trials(75% of Phase 1 trial costs in 2011), money disappears quite fast.
that was reported here last August and is not what I believe the $4MM was applied for.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52848568
This is all in regard to RFA 10-03,
http://www.cirm.ca.gov/files/grants/pdf/RFA%2010-03.pdf
"The number of applicants is small (CIRM said only four) because the round is limited to those who "have filed an Investigational New Drug application for the human pluripotent stem cell-derived therapy," according to the RFA. CIRM will accept trials involving both human embryonic stem cells and induced pluripotent stem cells. Both Geron and Advanced Cell Technology have filed the required applications."
rumit, no I haven't. The only review I see under RFA-10-03 is
Gerons for approx. $25MM
http://www.cirm.ca.gov/summary-application-ct1-05168
http://www.cirm.ca.gov/for-researchers/summaries-grants-review-reports
according to this link, Wednesday May 4,
8. Consideration of recommendations from Grants Working Group regarding applications submitted in response to RFA 10-03: CIRM Targeted Clinical Development Awards
http://cirm.ca.gov/agenda_2011-05-03/icocgoverning-board
hi louisa,
while only approx. 1/2 of 1% of the float it's better than nothing..:)
Advanced Cell Technology Praises Federal Appeals Court Ruling Allowing for Continued Federal Funding of Embryonic Stem Cell Rese
Advanced Cell Tech (OTCBB:ACTC)
Intraday Stock Chart
Today : Monday 2 May 2011
Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, today issued a statement about Friday's decision by the U.S. Court of Appeals for the District of Columbia on the legality of using federal funding for embryonic stem cell research. The ruling lifted an injunction which was imposed last year by a federal judge, who indicated that all embryonic stem cell research violated congressional spending laws.
Gary Rabin, interim chairman and CEO of ACT, read the statement:
"We applaud this federal court ruling and see it as a watershed moment for the regenerative medicine space. While ACT is not and never has been dependant on federal funding, we feel such funding is appropriate and could provide a tremendous boost to the industry. Many more researchers will hopefully now be able to engage in federally-funded research using our products, particularly stem cell lines derived using our patented "embryo-safe" blastomere technique for generating embryonic stem cells without damage to the embryo. We are very encouraged and will continue to work with the National Institutes of Health toward securing approval for federal funding of our embryonic stem cell lines derived using our blastomere technique."
johan and all,
some of the many reasons recruitment really couldn't get off the ground until now and will take some time.
Criteria
Inclusion Criteria:
•Adult male or female over 18 years of age.
•Clinical diagnosis of advanced SMD.
•If known, the patient's genotype will be recorded in the medical history, if unknown, patient will allow for the submission of a sample for genotyping.Clinical findings consistent with SMD.
•The visual acuity of the eye to receive the transplant will be no better than hand movement.
•The visual acuity of the eye that is not to receive the transplant will be no better than 24 (20/320) Early Treatment of Diabetic Retinopathy Study (ETDRS) letters.
•Peripheral visual field constriction documented on standard kinetic visual field testing.
•Electrophysiological findings consistent with SMD.
•Medically suitable to undergo vitrectomy and subretinal injection.
•Medically suitable for general anesthesia or waking sedation, if needed.
•Medically suitable for transplantation of an embryonic stem cell line:
•Normal serum chemistry (sequential multi-channel analyzer 20 [SMA- 20]) and hematology (complete blood count [CBC], prothrombin time [PT], and activated partial thromboplastin time [aPTT]) screening tests.
•Negative urine screen for drugs of abuse.
•Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) serologies.
•No history of malignancy.
•Negative cancer screening within previous 6 months:
•complete history & physical examination;
•dermatological screening exam for malignant lesions;
•negative fecal occult blood test & if over age 50 years, negative colonoscopy within previous 7 years;
•negative chest roentgenogram (CXR);
•normal CBC & manual differential;
•negative urinalysis (U/A);
•normal thyroid exam;
•if male, normal testicular examination; if over age 40, digital rectal examination (DRE) and prostate specific antigen (PSA);
•if female, normal pelvic examination with Papanicolaou smear; and
•if female, normal clinical breast exam and if 40 years of age or older, negative mammogram.
•If female and of childbearing potential, willing to use two effective forms of birth control during the study.
•If male, willing to use barrier and spermicide contraception during the study.
•Willing to defer all future blood, blood component or tissue donation. -Able to understand and willing to sign the informed consent.
Exclusion Criteria:
•History of malignancy.
•History of myocardial infarction in previous 12 months.
•History of diabetes mellitus.
•Any immunodeficiency.
•Any current immunosuppressive therapy other than intermittent or low dose corticosteroids.
•Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
•Current participation in any other clinical trial.
•Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
•Any other sight-threatening ocular disease.
•Any chronic ocular medications.
•Any history of retinal vascular disease (compromised blood-retinal barrier.
•Glaucoma.
•Uveitis or other intraocular inflammatory disease.
•Significant lens opacities or other media opacity.
•Ocular lens removal within previous 3 months.
•If female, pregnancy or lactation.
•Any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.
from trial info,
What is a DSMB?
http://bostonclinicalresearch.com/blog/bid/43771/What-are-Data-Safety-Monitoring-Boards-DSMB
Patients will be enrolled sequentially, and within each cohort of 3 patients, each patient's clinical course over the first 6 weeks following cell transplantation will be reviewed by an independent (DSMB) before enrollment is opened for the next 2 patients. A full safety assessment of all 3 patients in each cohort will be made by the DSMB when the 3rd patient in each cohort completes 4 weeks of follow-up, and before the first patient in the next cohort receives a cell transplant.