Dr. Christopher Rogers and Dr. Mary Ambach Publish the First US FDA-Approved Human Clinical Trial on GMP-Manufactured Stem Cell Therapy

Apr 29, 2024

We are pleased to announce that San Diego Orthobiologics Medical Group physicians, Dr. Christopher Rogers and Dr. Mary Ambach were first in the US to publish on the safety and efficacy of a GMP-manufactured stem cell product for patients with osteoarthritis. ¹ This FDA / IRB approved study was sponsored by Personalized Stem Cells (PSC), a leader in stem cell research for orthopedic conditions. ² 

Patients with moderate to severe knee osteoarthritis who had not responded to standard medical care were treated with PSC-01, an autologous, adipose-derived cell product, also known as stromal vascular fraction.  

Stromal vascular fraction (SVF) is obtained from a patient’s own adipose tissue (fat) using a simple in-office procedure. Prior clinical trials outside the United States have shown that SVF therapy is safe and effective for knee osteoarthritis. In several clinical trials, adipose-derived cells have demonstrated a superior ability to reduce pain, improve function and promote cartilage regeneration than bone-marrow derived cells. ^{3, 4, 5}

In this clinical trial, the treatment was shown to be safe, well-tolerated and effective. Most of the subjects had been advised to consider joint replacement surgery, however at one year follow-up, 79% were satisfied and able to avoid surgery altogether.  In addition, a single treatment was shown to decrease pain, increase function and improve quality of life for up to 2.5 years.

Treatments that use a patient’s own cells represent an exciting advancement in the field of orthopedic regenerative medicine.  SDOMG and PSC are committed to the responsible development of medical products that use a patient’s own cells to safely decrease pain and improve function.  While SVF products require FDA approval, this treatment offers real hope to all patients who suffer with joint pain.

To learn more about your current treatment options for orthopedic conditions, please schedule a consultation with one of our physicians today:

San Diego Orthobiologics Medical Group

6125 Pasel Del Norte, Suite 100

Carlsbad, CA 92011

(760) 909-2355

https://sdomg.com

[email protected]

REFERENCES

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11036882/pdf/scd.2024.0008.pdf
2. https://personalizedstemcells.com
3. https://www.thekneejournal.com/article/S0968-0160(21)00192-7/abstract
4. https://journals.sagepub.com/doi/abs/10.1177/03635465211014500
5. https://journals.sagepub.com/doi/abs/10.1177/03635465211053893