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

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
FDA Approval to Treat COVID-19 Patients Using Stem Cells

FDA Approval to Treat COVID-19 Patients Using 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

 

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