IS AUTOLOGOUS STEM CELL THERAPY SAFE?

Yes, autologous stem cell therapy is safe in both same day procedures as well as culture expanded stem cell therapy treatments. There is no evidence to suggest that mesenchymal stem cell therapies increase the risk of neoplasm in treated patients.

WHO IS A CANDIDATE FOR STEM CELL THERAPY?

Individuals that have been experiencing chronic pain in joints, ligaments and/or tendons or those who have failed conservative treatments are potential candidates for stem cell therapy.

For patients with mild to moderate arthritis in joints, there is good potential for cartilage regeneration and long-lasting improvements. For severe arthritis, there is less potential for substantial cartilage regeneration, although these patients may still notice improvements in subjective pain symptoms.

Partial tears of tendons and ligaments without significant retractions are excellent candidates for stem cell therapies as well.

How do I find out if I am a candidate for stem cell therapy?

We will first set up a consultation with the patient to assess pain and/or injuries. Optimally, we would like to review recent MRIs and x-rays. If patients have not had imaging studies done, we can arrange for these.

Does Boulder Biologics adhere to FDA recommendations for stem cell therapies?

Yes, we do adhere to FDA the recommendations for minimal manipulation and for homologous use per section 361 of the PHS Act and the regulations in Part 1271.

Learn more about the most recent FDA clarifications on stem cell therapies.

What is the difference between autologous mesenchymal stem cells, fetal tissues and embryonic stem cells? Is one better than the other?

Autologous mesenchymal stem cells are present in one's own bone marrow, adipose, muscles and synovial tissues. Embryonic stem cells only come from totipotent embryo cells in early fetal development, and, at this time pose ethical issues as well as higher risk for malignant potential in recipients. Fetal derived tissues can come from donor umbilical cord tissue, cord blood, placenta, chorion and amniotic fluid. The main concern with fetal derived tissues administered in the outpatient setting is that they are frequently mislabeled as "stem cells." However, there are very little live and/or viable cells in these products as they arrive in the form sold to pratictioners. Autologous stem cell therapies, when performed correctly, are the standard of care in outpatient regenerative medicine.

Who should do orthopedic stem cell treatments?

We recommend that only trained MDs and DOs with ample experience in the proper administration of stem cell therapies offer these treatments. Patients should be extremely careful about practice groups that have non-physicians performing these procedures, in consideration of the much higher likelihood that the stem cells are injected incorrectly.

Why use both bone marrow concentrate and adipose in the same joint?

Bone marrow concentrate contains mesenchymal stem cells as well as many others including immune factors, hematopoietic stem cells, epithelial stem cells and platelets. While the mesenchymal stem cells that are present in BMC is important, it may be equally so that the other additional factors play a substantial role in differentiation and proliferation of stem cells - and ultimately cartilage regeneration.

Adipose derived stem cells will on average have many more MSCs per mL than bone marrow aspirate, but adipose-MSCs may play a more important role in their capabilities as an extra-cellular matrix. Newer research is showing the importance of the ECM in terms of cartilage regeneration and the support of chondrocytes. Amable et al. studied protein synthesis and secretion in human MSCs from bone marrow, adipose and Wharton's jelly (umbilical cord) and determined that:

"Regarding extracellular matrix components, AT-MSCs (Adipose) secreted the highest amounts of collagen I, II, III and IV and WJ-MSCs (Umbilical Cord) did not secrete any detectable amounts of collagen II and IV... Collagen II is the most abundant protein in articular and hyaline cartilage; therefore WJ-MSCs would not be appropriate for cartilage regeneration since it would generate a fibrous tissue due to its higher collagen III secretion."

So, it is with the goal of cartilage specific stem cells and an ample and specific extra-cellular matrix, that we will typically use both bone marrow and adipose autologous tissues in large joints in particular.

Does Boulder Biologics offer IV stem cell therapies?

No, IV stem cell therapies are not offered at Boulder Biologics. Research is ongoing regarding the efficacies of IV stem cell therapies for diseases such as stroke and myocardial infarction. Studies have revealed the most of any stem cells given via IV, end up being trapped in the lung in rats (83% ± 6.3% SD), making this a poor choice compared to direct injection as done in orthopedic stem cell therapies. More concerns have arisen concerning stroke and vascular obstruction risks from intra-vascular administered mesenchymal stem cells. Considering that there is a 25% prevalance of patent foramen ovale in the general population, there is added risk of right to left heart migration leading to potential for embolic phenomenon in patients. We advise all patients to be extremely cautious of any clinics offering outpatient IV stem cell therapies unless being done in a research setting.

What is flow cytometry and what is it used for with stem cell therapy? Does Boulder Biologics use flow cytometry?

A flow cytometer is a lab device that uses laser precision optics to give accurate cell counts and quantitative assessments of cell viability, apoptosis and antibody labelling for cell type determination. Flow cytometry is used to determine cell count yields for patients and cell viability for stem cell therapy. We are able to scientifically perfect stem cell protocols by ensuring good cell yields and viability.

Yes, Boulder Biologics is using flow cytometry in-house and is able to provide patients with individualized flow cytometry results for their stem cell therapy.

Does insurance cover stem cell therapies?

Stem cell therapies are generally not covered by insurance at this time.