Aug 6, 2020
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.
Aug 4, 2020
STEM CELL RESEARCHERS AND THE FDA WARN PATIENTS ABOUT FRAUDULENT CLINICS THAT SELL ILLEGAL BIRTH TISSUE PRODUCTS
Stem cell therapies have the potential to treat many medical conditions that were previously untreatable. But, despite their enormous promise, stem cell therapies are only in the early stages of clinical development. For the past two decades, hundreds of scientific studies have been conducted, but much more work is required to prove the safety and efficacy of these treatments.
Recently, the FDA posted a warning to patients about the rising number of illegal stem cell clinics. In addition, a newly released short film documents the fraudulent and illegal activity of these stem cell clinics. Experts in the field were interviewed and shared their experience, warning patients about the fraud and abuse that is rampant in the United States.
Unscrupulous healthcare providers sell illegal birth tissue products and fraudulently promote them as “stem cell therapy”. These products include amniotic fluid, umbilical cord blood and exosomes. They are not FDA approved because they have not been tested for safety or efficacy. Physicians are not permitted to use them. In fact, patients have been harmed by them. And not surprisingly, none of these products have been shown to contain actual live stem cells.
Patient Education is Key
The physicians at San Diego Orthobiologics Medical Group support the experts and would like to educate patients about the risks of using illegal stem cell products. We only use FDA compliant cell therapies for our patients. We do not use birth tissue products because they have not been tested for safety or efficacy and are not permitted by the FDA. Our physicians are recognized leaders in the field of Orthobiologics, conduct FDA approved stem cell research and have published in the peer-reviewed scientific literature.
To learn more, please download our free E-book, The Patient’s Guide to Stem Cells.
Jul 24, 2020
Dr. Christopher Rogers, founder of San Diego Orthobiologics Medical Group (SDOMG) and medical director for Personalized Stem Cells, Inc. (PSC), is pleased to announce that they have obtained FDA approval to treat patients with severe COVID-19 using stem cells.
In record time, Personalized Stem Cells, Inc. has received approval from the U.S. Food and Drug Administration to conduct a clinical trial of stem cells for the treatment of patients with severe COVID-19 (1). Stem cell therapy has already shown encouraging results in studies conducted in Spain, Israel, and China. Dr. Rogers and his coauthors recently published a landmark peer-reviewed scientific article on the rationale behind the use of stem cells to treat COVID-19 (2). Support from entire team at SDOMG and PSC was critical to achieving this exciting accomplishment. We are eager to initiate this clinical trial and demonstrate the safety and efficacy of this innovative and promising therapy.
Resources
1) WFMJ: Personalized Stem Cells Receives FDA Approval to Treat COVID-19 Patients
2) Journal of Translational Medicine: Rationale for the clinical use of adipose-derived mesenchymal stem cells for COVID-19 patients
3) Personalized Stem Cells Announces Completion of Enrollment for FDA Approved Stem Cell Clinical Trial for Knee Arthritis
Jul 13, 2020
It has been more than fifty years since the first bone marrow transplant was performed to treat an infant with immune deficiency (1). In the years following that milestone, researchers and physicians have discovered new ways to use the bone marrow and its powerful stem cells to treat a number of different medical illnesses, including orthopedic conditions. Dr. Arnold Caplan discovered the mesenchymal stem cell in the early 1990’s (2). These cells are a specific type of adult stem cell found in the bone marrow that have the ability to renew themselves and differentiate into bone, tendon, cartilage and muscle cells.
Patients who suffer with joint arthritis, tendinopathy or ligament sprains benefit from bone marrow cell therapy, which stimulates the body’s natural ability to improve circulation, decrease inflammation and heal injured tissues.
What is Bone Marrow Aspirate Concentrate (BMAC)?
Although the name sounds complicated, bone marrow aspirate concentrate (BMAC) simply describes the source, method and process for removing cells from a patient’s own body, preparing them and reintroducing them into an injured area.
Bone marrow is a source of therapeutic cells. It contains powerful mesenchymal stem cells that can be collected for treatment. It also contains other Orthobiologics such as platelets, growth factors and proteins that contribute to the therapeutic effects. Aspirate refers to the way the therapeutic cells are collected into a syringe. About four tablespoons of bone marrow is removed (aspirated) from the back of the hip area. Concentrate is the term that describes how the bone marrow is processed. The aspirated bone marrow is transferred into a centrifuge that spins the sample, separating it into different layers and concentrating the therapeutic cells.
Is BMAC Effective?
BMAC has the ability to address the symptoms and root cause of spine and joint pain by decreasing inflammation and promoting the healing of the injured tissues. Current research and clinical experience have shown promising results in decreasing pain and stiffness, improving function and enhancing cartilage and bone healing in patients with osteoarthritis, tendon injuries and other orthopedic conditions. The benefits of these treatments typically last 2 to 5 years or longer.
This is a minimally invasive, non-surgical procedure that does not require hospitalization or lengthy rehabilitation. In fact, patients are back home within a few hours of the procedure and resume normal activities within a week. Most patients require only a single treatment, but it can easily be repeated if necessary.
To learn more about this exciting new treatment for orthopedic conditions, please visit us at: https://sdomg.com/bone-marrow-aspiration-concentrate-bmac-1/
Drs. Christopher J. Rogers and Mary A. Ambach of San Diego Orthobiologics Medical Group are board
certified in Physical Medicine & Rehabilitation and are recognized experts in orthobiologics therapies,
using cells and cell products to treat orthopedic conditions. They are stem cell researchers and
recognized leaders in the field of Regenerative Medicine. They have published extensively in the
scientific literature and have trained hundreds of physicians at medical conferences around the world.
Resources
1. M Health – Historical Milestones in Blood and Marrow Transplantation
2. Hindawi – Adult Mesenchymal Stem Cells: When, Where, and How
Jul 9, 2020
When: Wednesday, July 16, 2020
Time: 12:00 pm PST
“Tendon Injuries: Using Your Own Cells to Heal Your Body” Presented by Dr. Christopher Rogers and Dr. Mary A. Ambach
Join our free webinar to learn about non-surgical therapies to treat tendon injuries. Gain information on cutting edge treatments like platelet rich plasma (PRP) and other cell-based therapies. Get answers to your questions from Dr. Christopher Rogers and Dr. Mary Ambach, experts in the field of Regenerative Medicine
Your hosts:
Dr. Mary Ambach specializes in non-surgical orthopedics, regenerative therapies and interventional pain management. As a key thought leader in the field of Regenerative Medicine, Dr. Ambach conducts research, trains physicians and lectures at international medical conferences.
Dr. Christopher Rogers is one of the world’s leading experts in orthopedic regenerative medicine and a renowned speaker at national medical conferences. He has developed new approaches for the treatment of tendon injuries, osteoarthritis and disc degeneration which provide a safe and viable alternative to surgery.
Register for the FREE Webinar Here
Jul 8, 2020
DR. CHRISTOPHER ROGERS PRESENTS THE NON-SURGICAL OPTIONS TO JOINT REPLACEMENT AT A LIVE, WORLD-WIDE BROADCAST.
As an expert in the field of Regenerative Medicine, Dr. Rogers was invited to share his experience and the scientific evidence for the treatment of joint pain. Joint Replacement Awareness Day (JRAD) is an annual event sponsored by BoneSmart®, a worldwide patient engagement platform that brings awareness, education and support to patients throughout their entire joint replacement journey. More than 1.5 million Americans undergo joint replacement each year for painful osteoarthritis, yet most patients prefer to avoid surgery when possible. Treatment with Orthobiologics such as platelet rich plasma (PRP) and other cell based therapies are a safe and effective option for patients wishing to avoid or delay joint replacement surgery.
Watch the full presentation here:
