Stem Cell Therapy FAQs

We have composed a list of the most common questions patients have regarding stem cells and stem cell therapy. If your questions are not answered below please feel free to contact our office 303-449-8807

 

What are Stem Cells?
Human stem cells are found in the embryo and in adults. Embryonic stem cells have the potential to form every type of cell in the body. Adult stem cells are called Mesenchymal Stem Cells (MSC’s) and are more limited in their ability to form different tissue than embryonic stem cells. Our bodies rely on stem cells in our skin to form new skin cells as old ones die and stem cells from our bone marrow form new red blood cells to replenish the 15 million that die every second. MSC’s have been used to generate tissue such as muscle, bone and cartilage in a laboratory environment. When injected into areas of inflammation or injury, MSC’s signal cells in the area to grow or proliferate. In addition, MSC’s have powerful anti-inflammatory properties and calm down the immune system, thus counteracting proteins and enzymes that cause tissue to degrade or break down. MSC’s also have antibacterial properties. Due to the multi-function of MSC’s, Dr. Arnold Caplan, who discovered and named MSC’s in 1988 has proposed the name be changed to Medicinal Signaling Cells.
Do amniotic products have stem cells?
Though many products are described as “Amniotic Stem Cells,” the stem cells in these products are dead and not viable. If they did contain live stem cells, they would be considered 351 tissue and necessitate lengthy and expensive FDA approval. Manufacturers of these products market them with the designation that they are 361 tissue.

Here is a link explaining the difference between 351 and 361 tissue: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2016/03/proposed-legislation-would-create-a-new-conditional-approval-pathway-to-market-for-regenerative-medi.html
What is Regenerative Medicine?
Regenerative medicine is the engineering or regeneration of tissue to repair, replace, maintain or enhance organ function which has been damaged by injury, disease or aging.(A. Caplan, 2015)
Does stem cell injection/regenerative medicine work
Concentrated doses of MSC’s administered to areas of injury or inflammation in human studies have shown that MSC’s signal cartilage cells to grow and form new cartilage, increase the success rate and healing of rotator cuff repair, improve symptoms of osteoarthritis and regenerate meniscus cartilage.

There are currently several hundred MSC studies being perform worldwide: https://clinicaltrials.gov/ct2/results?term=mesenchymal+stem+cells&pg=6
How are MSC's harvested and administered?
There are several methods for harvesting, concentrating and administering MSC’s. At Boulder Regenerative Medicine, MSC’s are derived from fat areas of the stomach or sides of the back.

Fat Harvest
Using sterile technique, local anesthetic is used to numb the abdominal area. Sterile saline is injected into the fat to loosen the tissue. The fat is withdrawn into a syringe and placed into a patented system using agitation with small stainless steel balls suspended in saline to separate the MSC’s and fat from the undesired oil, blood and cellular debris. This preparation is injected into the desired location. The fat graft yields 3-500X more stem cells/cc than bone marrow.

in-office video of this procedure.


  Dr-Arnold-Caplan-Stem-Cell-Therapy-Boulder-Regenerative-Medicine

Dr. Arnold Caplan explains the fat harvest process in THIS VIDEO taken at an Orthobiologic Institute Regenerative Medicine Symposium in June 2016.

View complete Caplan presentation HERE.
Is the procedure FDA approved?
MSC’s are considered 361 Tissue and FDA approved when they are harvested from and re-administered to the same individual, are not grown in a lab or manipulated either with drugs or mechanically. When fat-derived MSC’s are used at Boulder Regenerative Medicine, they are classified as 361 Tissue. The following conditions are treated with Regenerative Medicine at Boulder Regenerative Medicine:

Osteoarthritis
Knee
Shoulder
Ankle
Hip
Elbow
Meniscus Tears
Rotator Cuff Tears
ACL Tears
Chronic Tendonitis
Partial Tendon Tears
Who preforms the procedure?
Dr. Joanne Halbrecht performs all procedures. She is a board certified orthopedic surgeon fellowship trained in sports medicine with over 20 years of experience in private practice.
How do I know if I'm a candidate for regenerative medicine?
Studies such as X-Rays and MRI’s as well as medical history, symptoms, physical examination and records are reviewed by Dr. Halbrecht. She discusses her recommendations with the patient and together, a treatment plan is formulated.