What Are the Risks & Benefits of Cell-Based Treatments?

What Are the Risks & Benefits of Cell-Based Treatments?

Many people are discovering the benefits of cell based therapies, commonly known as stem cell treatments, in treating orthopedic conditions such as osteoarthritis, tendon injuries and chronic low back pain. These treatments have offered patients hope for long term pain relief and healing. Patients have obtained significant medical benefits from physicians who offer safe and evidence based cell therapy.

Although there is increasingly abundant data on the benefits of these treatments, many stem cell therapies are in the investigational stages of development. The U.S. Food and Drug Administration (FDA) regulates the use of stem cells in clinical practice. Healthcare providers that offer cell based therapies are obligated to comply with state and federal regulations. 

Unfortunately, in the U.S. there are more than 600 clinics that promote stem cell treatments that are neither safe nor effective. The level of healthcare provider training at these clinics is highly variable with many delivering treatments from unqualified individuals.  So when patients ask, “Does stem cell treatment work?”, the answer is, “It depends on the clinic what they are offering as stem cell treatment.”.  We believe it is important for physicians and their patients to understand the key differences between cell based treatments and the providers who offer them.

Several “stem cell” clinics use birth tissue derived from umbilical cord blood or amniotic tissue.  Others will offer exosomes which are products derived from stem cells.  These products are not FDA compliant for orthopedic use.  They require FDA approval of a Biologics License Application before physicians are permitted to market them to patients.  In an effort to evade FDA scrutiny, the manufacturers of these products claim that their birth tissue products do not contain live stem cells.  Yet the clinics that sell these products make very different claims.

What sets San Diego Orthobiologics Medical Group apart from other clinics is our commitment to only use FDA compliant cell based therapies that are supported by the scientific evidence.  In addition, we use cells that are obtained from the patient’s own body (autologous cells) to maximize safety.

Two Sources of Cell-Based Treatments

Stem cells are found throughout the body.  Common sources used to obtain stem cells are bone marrow aspirate concentrate (BMAC) and adipose tissue (fat) that has been processed in an FDA compliant manner.  These tissues are known to contain live stem cells, however it is difficult to accurately measure the number of cells at the time of treatment.  In addition to stem cells, there are many other kinds of cells in bone marrow and fat that contain healing properties.  Cell based treatments that are obtained from these tissue sources comply with current FDA guidelines and are supported by several scientific studies that report on the safety and efficacy of these therapies for orthopedic conditions.

  • Adipose-derived cells are collected from a mini-liposuction procedure, typically from the abdomen or buttocks.  San Diego Orthobiologics Medical Group offers  LIPOGEMS® autologous fat tissue product for treating joint and soft tissue injuries. LIPOGEMS® preserves cells within the fat without jeopardizing their native structure. This enables reparative cells within the fat to continue to work as a functional unit allowing the body to repair damaged or degenerated tissues.
  • Bone marrow derived cells contain a rich supply of cells that have been shown to stimulate the body’s ability to improve circulation, decrease inflammation and heal injured tissues. San Diego Orthobiologics Medical Group offers bone marrow aspirate concentrate, which provides a significant amount of regenerative cells to support the body’s natural healing response.

Patient Safety is Paramount

Because San Diego Orthobiologics Medical Group uses a patient’s own tissue, there is minimal risk of disease transmission, infection or immune reaction.  This would not be the case for donor birth tissue derived products.  Moreover, autologous cells used in our treatments are preserved in their natural state and possess the greatest healing potential. Donor or birth tissue products have not been proven to be safe or effective for orthopedic conditions. There have been cases of bacterial infection with the use of donor products and most do not contain any living stem cells at all.

In addition to using a patient’s own cells, San Diego Orthobiologics Medical Group also protects our patients using:

  • State of the art cell processing techniques in our Orthobiologics lab using some of the most advanced regenerative medicine technology in San Diego.
  • Innovative equipment to image the joint and spine such as musculoskeletal ultrasound and fluoroscopy (digital x-ray). These tools provide detailed visualization of the injured structures and significantly improve the comfort and effectiveness of cell based therapies.
  • Fellowship trained physicians who have decades of experience treating patients with orthopedic conditions.  We also track our safety and efficacy outcomes with the DataBiologics registry to help patients make informed medical decisions.

An Investment in Safety

San Diego Orthobiologics Medical Group invests significant time and expertise to ensure we offer FDA compliant and evidence based therapies in order to provide our patients with safe, comfortable and effective treatments. As dedicated healthcare professionals, we understand that every patient is unique and that the best outcomes are derived after a comprehensive evaluation, patient education of all treatment options and customized medical care.

Drs. Christopher J. Rogers and Mary A. Ambach of San Diego Orthobiologics Medical Group are experts in the field of regenerative medicine and have been providing safe, effective and FDA-compliant cell based treatments to their patients for decades. They serve as faculty members and lecturers at national and international medical conferences and are considered experts in the field of regenerative medicine.




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