US Stem Cell Inc (USRM)

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Recent Blog.
Greetings,
Kristin Comella
Chief Scientific Officer

The field of regenerative medicine is rapidly developing new therapies to offer hope to patients who previously had very limited options. Bioheart, founded in 1999, has been at the forefront of these developments for over 15 years. We treated our first human patient in 2001 with muscle stem cells, or myoblasts.

Our product, MyoCell, has been the subject of nearly a dozen peer reviewed journal articles and has been reported on by many prominent speakers. The results of the MARVEL trial speak for themselves. In the double blind placebo controlled MARVEL trial, myoblast treated patients increased in exercise capacity by 95.6 meters while control patients declined by 3.6 meters after 6 months. This is double the improvement that was reported by others in autologous bone marrow and cardiac stem cells trials and more than eight times better than results published in allogeneic bone marrow studies. We are continuing to study this therapy in double blind placebo trials including MARVEL part 2 and MIRROR. We intend to continue the placebo trials including MARVEL part 2 and MIRROR—and continued enrollment in placebo trials including MARVEL part 2 and MIRROR studies is dependent on obtaining the necessary funding. Because they are double blind placebo controlled studies, results will only be presented after enrollment is complete.


Since its inception, Bioheart has striven to break new ground in regenerative medicine and had published many “firsts” for the field. We were the first company to gain approval from the FDA for a phase I study for a combined cell and gene therapy product for congestive heart failure patients. This type of therapy truly defines the world of regenerative medicine where we combine different modalities of regeneration to reverse the effects of disease and aging.

Approximately 7 years ago, our team began working with adipose derived stem cells (ADSCs) and currently market this product under the name AdipoCell™. We have completed a variety of animal studies to demonstrate that the cells can engraft and promote healing. ADSCs have the ability to increase angiogenesis or formation of blood vessels which makes this therapy appropriate for a variety of degenerative diseases with ischemic tissue. The cells are naturally anti-inflammatory and can suppress an over reactive immune system.

Since that time, together with our team of physician collaborators, we have completed over 3500 patients for a variety of conditions. We are currently working with the Global Stem Cell Group and Stem Cell Training Inc. to train physicians on these therapies for use in their clinic. We are currently studying the use of AdipoCell in the following applications: osteoarthritis, rheumatoid arthritis, degenerative disc disease, COPD, diabetes, erectile dysfunction, heart disease, critical limb ischemia, and more. In fact, we have recently received approval for several IRB studies which are listed on www.clinicaltrials.gov. We feel that it is important to gather important safety and efficacy data to fully understand the expected outcomes with these therapies.

We recently released the preliminary 6 month data from our phase I ANGEL Trial. Fully funded by Bioheart, the trial is being conducted in Mexico at the Hospital Angeles in conjunction with the Regenerative Medicine Institute (RMI). This phase I study will provide necessary safety and preliminary efficacy of AdipoCell in patients with congestive heart failure. Endpoints include safety, exercise capacity, quality of life, and ejection fraction at 3 months, 6 months and 12 months.

At the 6 month time point, patients are demonstrating an average improvement in exercise capacity or a six minute walk test of approximately 68 meters as compared to an average improvement of 47 meters at 3 months. Eighty percent of the patients showed an improvement in their exercise capacity from 3 months to 6 months post stem cell injection.

Another end point in the study is ejection fraction (EF) by echocardiogram. At the 3 month time point, 100% of the patients demonstrated either improvement or stayed the same. After 3 months, patients showed an average absolute improvement of 3 percentage points in ejection fraction. The patients continued to improve from 3 months to 6 months with a statistically significant average absolute improvement of 10 percentage points (p=0.01). I will present the full six month data at the upcoming Age Management Medicine Group conference in Orlando on April 25th (www.agemed.org).

Another service that we offer to our network of physicians is stem cell banking. We are a registered FDA tissue bank and can process, culture expand and cryopreserve tissue for interested patients. We are working with several hundred physicians who are currently making these services available to their patients. We are able to bank stem cells from fat, bone marrow and cord blood. We work with several clinics outside the US so that patients may receive these banked doses including two in Mexico, Jamaica, and Honduras.

One of our newest projects is cellular based immunotherapy. Cellular based immunotherapy is a method to help a patient’s immune system recognize and stop cancer. Bioheart has entered into an exclusive agreement to license three different cellular based immunotherapy patents from inventor Allan Wu, M.D. Dr. Wu has invented a method of immunotherapy for the treatment of malignant tissues using a unique mixed population of cells and antigen sources. Animal studies in dogs are underway. We have successfully completed the first set of experiments using canine cells and we are now beginning to dose those animals. We are expecting results on this project later this year. If successful, we will offer a new solution to dogs who are suffering from terminal cancers.

Our team at Bioheart is constantly working to advance the field of Regenerative Medicine. As a small start-up company, our team can remain focused on bringing the newest therapies to patients without the hindrances of big company bureaucracy. We are bringing the latest techniques to the clinic to help defeat some of the toughest diseases.

Feel free to email me directly with any questions about our research or current projects.

Warm regards.
Kristin Comella

Chief Scientific Officer

- See more at: http://investorstemcell.com/ceo-blogs/bioheart-cso-update/#sthash.U0h7WW3c.dpuf