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

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
FREE Webinar: Not all PRP is Created Equal

FREE Webinar: Not all PRP is Created Equal

Join Dr. Evangelista to learn more about Platelet Rich Plasma in a free webinar. For patients seeking treatment with Platelet Rich Plasma (PRP), Dr. Evangelista will discuss:

  • The differences in PRP processing systems
  • Platelet dose matters: does your PRP have enough?

  • Getting your PRP to the target- the importance of expertise and image guidance

Time: 12pm PDT

When: Tuesday, April 9, 2024

Dr. Evangelista has a special interest and extensive training in Regenerative Medicine (using the body’s own cells to stimulate the healing and repair of injured tissues).  He believes these treatments have tremendous potential for treating a variety of orthopedic and pain conditions.

Click Here to Register

Dr. Mary Ambach’s Intradiscal Biologic Spine Study is Published

Dr. Mary Ambach’s Intradiscal Biologic Spine Study is Published

Congratulations to Dr. Ambach who is one of the investigators in this landmark study and co-author of the paper. This is a multi-center randomized placebo-controlled clinical trial using platelet rich plasma (PRP) and Bone marrow derived cells to treat degenerative disc disease in the lumbar spine. These cells were derived from the patient’s own blood and bone marrow. The study was able to show safety and superiority of PRP and Bone marrow derived cells over placebo in treating low back pain due to degenerative disc.

Read the full paper here: https://pubmed.ncbi.nlm.nih.gov/38285032/

SEE MORE: The Safety and Effectiveness of Orthobiologic Injections for Discogenic Chronic Low Back Pain

FREE Webinar: Translating Stem Cell Research Into Long-Lasting Joint Pain Relief Without Surgery

FREE Webinar: Translating Stem Cell Research Into Long-Lasting Joint Pain Relief Without Surgery

Join Dr. Rogers and Dr. Diaz as they discuss the exciting results of their latest stem cell research and experience with FDA-compliant cell therapies that are available.

Time: 12pm PDT

When: February 27, 2024

Dr. Rogers is one of the world’s leading experts in orthopedic regenerative medicine and developed a new technique for treating tendon injuries, osteoarthritis, and disc degeneration.

Dr. Diaz specializes in comprehensive non-surgical treatments for musculoskeletal and sports-related injuries. She is constantly educating herself so she can better serve her patients using state-of-the-art therapies and advanced treatments in her field.

Click HERE to Register

Dr. Rogers and Dr. Ambach Presented Keynote Address at Interventional Orthobiologics Foundation Conference

Dr. Rogers and Dr. Ambach Presented Keynote Address at Interventional Orthobiologics Foundation Conference

Last week, San Diego Orthobiologics Medical Group physicians, Dr. Chris Rogers and Dr. Mary Ambach were featured speakers at the annual Interventional Orthobiologics Foundation (IOF) conference.

The Interventional Orthobiologics Foundation is a leader in the field of Regenerative Medicine, having trained more than 1000 physicians.

Each year, the those the IOF MAX Experience where more than 250 orthopedic physicians from around the world come to learn the latest in cell-based therapies such as Platelet-Rich Plasma (PRP) and stem cell therapy.

This year, Dr. Rogers and Dr. Ambach were honored to be selected to both moderate the event and present the keynote address.

To view their presentations, you can visit the SDOMG YouTube Channel.

dr. rogers at interventional orthobiologics foundation conference rogers and ambach at interventional orthobiologics foundation conference Ambach presenting at IOF conference Dr. Ambach presenting at Interventional Orthobiologics Foundation conference

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