Current Development of Cell-based Therapies in the United States

Current Development of Cell-based Therapies in the United States

Medical research advances enable physicians to find new and innovative ways to use the body’s systems to fight disease and injury.

Regenerative medicine is a field of medicine that uses the body’s own cells and tissues to heal injuries and medical conditions. In the treatment of cancer the cells are used in immunotherapy, which involves modifying patient’s cells to fight the disease. In the field of orthopedics, regenerative medicine specialists use the patient’s own blood cells, bone marrow or adipose tissue to help the body boost its own natural healing properties. These are known as orthobiologics.

At the present time, FDA allows the use of autologous orthobiologics —which means the tissue or cells used must come from the same patient. Donor  products are not allowed to be used in clinical setting unless it is used under the purview of a clinical trial. Read here on the FDA guidance on the use of human cells and tissues.

Cell-based Treatments for Orthopedic Conditions

There are two types of cell-based therapies that can be used to treat orthopedic conditions:

Bone Marrow Aspiration Concentrate (BMAC): Bone marrow-derived cells are collected from the back of the pelvic bone. The marrow contains mesenchymal stem cells which have the ability to renew themselves and differentiate into bone, tendon, cartilage and muscle cells. These make them an ideal therapy for treating orthopedic injuries such as tendon tears, worn cartilage, and degenerated disc disease. BMAC also contains important therapeutic cells, growth factors and proteins that stimulate the body’s natural ability to improve circulation, decrease inflammation and heal injured tissues. 

Micro-fragmented Adipose Tissue (fat) Cells:  Adipose-derived cells are collected from a fat sample usually from the buttock or abdomen. There is minimal manipulation of the tissue with no enzymatic digestion or addition of other biological or pharmacological agents. Fat or adipose tissue is rich in healing cells like mesenchymal stem cells or MSCs, growth factors and other proteins that can assist in healing tissues. 

Why Consider Cell-Based Therapies?

There is increasing body of clinical research that demonstrates the safety and efficacy of Cell based therapies. A recent comprehensive report 1  based on actual clinical data collected from 65 physicians at 43 clinics in 25 states revealed that seventy percent of the patients treated with adipose tissue therapy reported a meaningful reduction in pain at 12 months following treatment and sixty-one percent of the patients treated with bone marrow aspirate reported a meaningful reduction in pain at12 months following treatment. 

Micro-fragmented adipose tissue or bone marrow aspirate concentrate is a non-surgical treatment option that does not involve incisions, general anesthesia, hospitalizations or lengthy rehabilitation stays. This is an outpatient procedure performed in a doctor’s clinic using only local anesthesia.

Patients considering cell-based therapies should do their research in ensuring they get the best treatment. There are several important factors that can impact the effectiveness of these treatments. These include:

  • Cellular product preparation:  The patient’s bone marrow or fat tissue must be processed using FDA compliant devices and protocols. It must be prepared in a safe and sterile environment by medical personnel who are trained in the proper handling of these tissues. 
  • Delivery: The procedure must be performed by skilled physicians who are properly trained in this field. They must be able to perform these highly specialized injection techniques using imaging guidance to ensure that the cellular products are delivered to the site of injury.
  • Experience: The field of regenerative medicine is changing daily and there are a limited number of specialists around the country who have the experience and technology to perform cell-based orthopedic treatments safely and effectively. Dr. Mary A. Ambach and Dr. Chris Rogers have decades of experience in using regenerative therapies and are nationally recognized experts in this field. 

 1Databiologics. An Overview of Regenerative Treatments for Orthopedic Conditions. 2021 Outcomes Report.

Now You Can Help Your Body Heal Itself

Now You Can Help Your Body Heal Itself

Regenerative medicine represents a complete breakthrough in modern medicine.  The body’s ability to heal itself naturally is actually not a new thing.  A fractured bone will regrow and heal the break.  Cut yourself shaving, and the skin will heal.  There are many examples of our body’s innate ability to heal injuries.

Now modern science and technology are now enabling physicians to help their patients discover new ways in which the body can heal itself.  Within the specialty of orthopedics, regenerative medicine is offering healing and pain relief to patients who suffer from conditions such as osteoarthritis, herniated discs or ligaments and tendons injuries. 

Orthobiologics Can Boost the Body’s Own Natural Healing Abilities

Orthobiologics are cells and substances derived from cells that are naturally found in your body. By concentrating them and delivering them to the site of injury, they can help speed up the healing process.

Here’s how it works:

When you injure a bone, muscle or tendon, the platelet cells in the blood are the first responders arriving on the scene to quickly start healing. White blood cells also rush to the injury site to ward off infection, control inflammation and become the clean-up crew [i].  Other important cells like stem cells participate in this complex symphony of repair.  Specialists in orthopedic regenerative medicine can now boost these natural processes through several specialized treatments that help maximize the body’s own innate healing capabilities.

Regenerative Treatments for Orthopedic Conditions

There are different orthobiologic treatments that your regenerative medicine specialist can recommend depending on your orthopedic condition:

·  Platelet Rich Plasma puts the healing properties of the patient’s own blood to work to repair damaged joints, tendons and muscles. The platelets in the blood release growth factors and proteins that promote tissue repair, while the plasma carries the hormones, electrolytes and nutrients required to nourish cells during the healing process.  PRP treatments are customized to the particular individual and their injury in order to be most effective.

·  Cell based therapies use cells derived from the patient’s own bone marrow or adipose (fat) tissue. These cells include adult stem cells and many other healing cells. They produce molecules that direct neighboring cells in the area to form new blood vessels, decrease inflammation and encourage formation of new healthy tissues.  Stem cells are special cells that have the unique ability to develop into the specific kind of cell needed, whether that be a tendon, ligament, cartilage or bone cell. Skilled regenerative medicine practitioners use highly specialized processes to prepare these cells that are then delivered directly to the injured area to stimulate healing.

·   Prolotherapy (Proliferative Therapy) uses dextrose and other natural substances that are injected into a chronically injured ligament, tendon, nerves or joint in order to help the body jump-start its own natural healing response.

Beware of Imposters

As regenerative treatments have become more widely recognized for their ability to address  orthopedic conditions and the chronic pain associated with it, more and more clinics are trying to get in on the action.

If you are considering regenerative treatments for pain related to osteoarthritis, tennis elbow, degenerative discs in the spine or other conditions, you should perform due diligence on the clinic that offers it.  The source, processing and delivery of the regenerative materials are critical to the success of the treatment.

Currently, the U.S. Food and Drug Administration (FDA) does not allow the use of stem cells derived from birth tissue products (amniotic fluid and tissue, umbilical cord blood) to treat orthopedic conditions because these donor products have not been proven to be safe or effective.  Our board-certified specialists only use your own cells (autologous) to treat orthopedic conditions.

Maximizing the effectiveness of these treatments requires a state-of-the-art facility and equipment, as well as knowledge and experience in fluoroscopic (x-ray) or ultrasound guidance to ensure targeted delivery of the healing cells to the injured area.

Orthobiologic treatments that capitalize on the body’s own natural healing abilities is one of the most exciting opportunities in modern medicine to address and resolve the chronic pain associated with orthopedic conditions that affects millions of Americans.

Drs. Christopher J. Rogers and Mary A. Ambach of San Diego Orthobiologics Medical Group together have successfully treated thousands of patients with cell based therapies for more than three decades.  They are published authors and cell therapy researchers.  Their facility in Carlsbad contains the most advanced Regenerative Medicine technology in San Diego and offers same day treatments with the highest level of safety and efficacy.



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