Stem Cell Treatments: Hope Hype or True Regenerative Medicine
This field joins nearly all disciplines of science and holds the realistic promise of repairing damaged tissue by harnessing the body’s ability to heal itself through stem cell treatments. As with any major scientific breakthrough, the market has become inundated with “stem cell treatments” and stem cell products that promise to do everything from cure disease to provide cosmetic enhancement. The following is a guide for consumers interested in safe and efficacious treatment.
Adult stem cells are found in every part of the body and have the potential to develop into many different cell types. As a stem cell divides, each new cell has the ability to either remain a stem cell or become another cell type with a more specialized function. Stem cells are characterized by two functions from other cell types.
First, they are unspecialized cells capable of renewing themselves by cell division. Second, they have the ability to become specialized cell types. Unlike embryonic stem cells, which are derived from human embryos, adult autologous stem cells are harvested from a patient’s own tissue, such as adipose (fat) tissue or bone marrow.
Stem cells derived from a patient’s own fat are referred to as adipose-derived stem cells. Adipose-derived stem cells or ADSCs have been shown clinically to differentiate, or become different cell types including cartilage cells, bone cells, nerve cells, skeletal muscle, and adipocytes (fat cells).
Several beneficial effects have been associated with adipose-derived fat cells, including the ability to reduce inflammation and promote tissue healing through the secretion of growth factors and signaling molecules (cytokines), which recruit stem cells to facilitate repair and healing of the affected tissue. Additionally, these cells provide a network for blood supply while the tissue heals.
We have developed and validated a method for harvesting and isolating stem cells from fat for therapeutic use. Using this method, we are able to provide treatments in a variety of degenerative diseases. Stem cells can be harvested and separated from adipose tissue under local anesthesia in a medical office setting.
This procedure should be performed under sterile conditions under a doctor’s supervision. The accepted method of adipose-derived stem cell harvesting involves tumescent liposuction. The fat is then processed to separate the stem cells from the adipose tissue using a special enzyme along with centrifugation and filtering processes to provide the final stem cell product, often referred to in the medical community as the stromal vascular fraction.
The stem cell isolation process should be a validated method that provides a consistent cellular product and is compliant with current regulatory guidelines. This means that studies should be conducted to test the procedure used to ensure that it is safe, provides a predictable amount of stem cells, and results in a purified and effective product for patient’s use.
In our clinics we utilize materials that are produced according to Good Manufacturing Practices (or cGMP) set forth by the FDA. We are collecting approximately one million cells per cc of fat extracted. This procedure consistently produces pre-determined acceptance criteria, making it easy to duplicate in a medical office setting and has been validated via reproducibility and robustness analysis.
Obtaining a cellular product that is capable of proliferating and differentiating requires detailed analysis and this is critical to ensure reliable patient outcomes. We have trained hundreds of physicians in the responsible aspects of stem cell treatments so that they can provide a safe and effective treatment to their patients.
In conjunction with both the Regenerative Medicine Institute (RMI) and Bioheart, Inc., the Ageless Regenerative Institute (ARI), is conducting clinical trials for many degenerative diseases using adipose-derived stem cells. There are approximately thirty protocols that have been approved by the Institutional Review Board of Hospital Angeles, Tijuana, a JHACO-certified, state of the art private specialties hospital providing high quality chronic disease treatments with a patient-centered focus.
Many of these protocols can be found at www.clinicaltrials.gov and include treatments for congestive heart failure, myocardial infarction (heart attack), ischemic limb disease, diabetes, and chronic pulmonary obstructive disease (COPD).
Early results are promising for the clinical trials being conducted in conjunction with our scientific partners for chronic obstructive pulmonary disease (COPD), congestive heart failure, and ischemic limbs.
Outcome measurements for the COPD study include safety, exercise capability, and quality of life assessment. Thus far 35 patients have been treated and results demonstrate an increase of 174 meters in a six-minute walk test when compared to baseline at three months.
These results are further substantiated by positive patient testimonial and 83 percent statistically significant improvement in quality of life. This represents a new breakthrough for COPD patients who often suffer a progressive decline in health following diagnosis.
In a protocol focused on congestive heart failure, fifteen patients have been successfully treated with adipose-derived stem cells. Outcome measurements for this study include safety, changes in left ventricle ejection fraction, exercise capability in terms of a six-minute walk test, and quality of life assessment. In these treatments, autologous stem cells are harvested, processed, and delivered to the damaged area of the heart muscle via catheter.
Study patients have demonstrated on average, an absolute improvement of 11 percentage points in injection fraction and an increase of 128 meters over baseline in their six-minute walk test at their six-month follow-up. This means that the patient’s heart appears to be functioning better on an echocardiogram. In addition, the patients’ exercise capacity has improved, which allows for a more active and normal lifestyle.
This data is in agreement with many years of pre-clinical animal studies completed by ARI and Bioheart, demonstrating the safety and efficacy of this therapy; including a study led by Keith March, MD, PhD, director of the Vascular and Cardiac Center for Adult Stem Cell Therapy at Indiana University. The results of these studies showed the tendency of adipose stem cells toward heart muscle regeneration and growth of new blood vessels.
This action by the adipose-derived stem cells makes them the perfect therapy from ischemic tissue. Critical limb ischemia is a condition where the blood supply is compromised to the lower limbs, causing tissue death and often results in amputation.
Hundreds of patients have been successfully treated with adipose-derived stem cells for limb ischemia with end results being limb salvage due to increased blood flow to the area, a result of the development of new, healthy, functioning blood vessels in the affected area.
We have recently developed a protocol for treating patients that have non-healing ulcer wounds due to radiation. In the case study presented below, we delivered stem cell in and around the wound due to radiation necrosis. This patient had attempted several traditional therapies including a skin graft which was not successful.
ADSCs promoted the growth of new blood vessels and promoted healing of the tissue. After six months, the wound has completely healed and the patient has resumed normal activities. In addition, the angiogram demonstrates the formation of new blood vessels in the effected leg.
In the area of regenerative orthopedics, the treatment technique involves using adipose-derived stem cells combined with platelet rich plasma (PRP), which is injected into the affected area using sterile technique. This treatment is appropriate for patients with degenerative orthopedic conditions and musculoskeletal injuries.
Average improvements following stem cell/PRP injections over baseline, using a visual analog scale, pain scale, and range of motion scale show an 80 percent improvement in 200 knee treatments, 75 percent improvement in 175 hip treatments, and 70 percent improvement in 50 shoulder treatments.
The Ageless Institute is currently conducting these treatments under Independent Review Board (IRB) studies in the U.S. to further study the long-term effects of these results for orthopedic conditions.
As the data suggests, stem cells possess enormous regenerative potential. Adipose stem cells can be obtained from the patient easily, abundantly, and with minimal patient discomfort. The potential applications are virtually limitless.
Clinical applications for patients can be performed in a medical office setting safely, legally, and ethically using autologous adipose-derived stem cells. Before undergoing any stem cell treatments, patients should use the following checklist as a guide to determine if the treatment is the best option for them:
- Physician’s credentials and experience: how long have they been performing these treatments, what training/education/experience do they possess.
- Has the physician been sanctioned by their State Medical Board or any other regulatory agency?
- Method of obtaining the stem cells: is it a validated method? Can they provide you statistics to support this?
- Will the cells be harvested, processed and re-implanted in the same setting?
- What research or statistics can be provided on the success of the treatment?
- What are the possible complications/adverse effects of the treatment?
- How many treatments has the physician performed?
Patients should only receive cutting edge treatments that are safe, compliant, and efficacious. One day, stem cell treatments will be the gold standard of care for the treatment of most degenerative diseases. Until then, patients should be diligent and fully research and understand the procedures they are choosing to undergo. Remember, if it sounds too good to be true, it most likely is not effective.
About the Authors
Dr. Sharon McQuillan developed the Ageless BodySculpture technique. After years of performing BodySculpture, it became apparent that there were regenerative stem cells in the fat being removed from her patients during BodySculpture procedures. In 2009, she formed The Ageless Regenerative Institute in conjunction with an international team of experts from the medical, legal, biotechnical, and manufacturing arenas. Additionally, Dr. McQuillan in collaboration with Ageless Regenerative Institute’s Chief Scientific Officer Kristin Comella, has authored over thirty clinical trials which harness the patient’s own healing power of their stem cells to treat various degenerative conditions.
Ms. Kristen Comella has over 14 years experience in corporate entities with expertise in regenerative medicine, training and education, research, product development, and senior management. Ms. Comella has been a member of the Bioheart Inc. senior management team since 2004 and is currently serving as the Chief Scientific Officer. Bioheart is a publically traded company focusing on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Ms. Comella was appointed as Bioheart’s Vice President of R&D and Corporate Development in December 2008. Since joining Bioheart in September 2004, she has played a major role in managing the product development, manufacturing and quality systems. She is co-founder and Chief Executive Officer of Stemlogix, LLC and Chief Scientific Officer of the Ageless Regenerative Institute.
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