Medical Provider Information Download
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Approximately 28mb PDF download.
Other General Information
Regenexx-SD Procedure: Information for Health Care Providers
Stem cells are heavily advertised all over the Internet. We recognize the need for significant basic science information on stem cell therapies so that consumers and medical professionals can make informed decisions.
What type of stem cells are these?
These are the patient’s own (autologous) bone marrow derived mesenchymal stem cells (MSC’s) and Hematopoetic Stem Cells (HSC). They are isolated in the lab from a bone marrow aspirate via a nucleated cell isolation.
How much clinical experience do you have with the use of stem cells?
We began using stem cell concentrates in 2005-2006 and then cultured stem cells in 2006 in human subjects as part of IRB approved research studies. As a result, our medical practice has as much or more experience in the use of mesenchymal stem cells for orthopedic conditions as any other site in the world. We have performed thousands of stem cell based procedures.
Is this the same as BMAC or a bone marrow concentrate prepared at the bedside in a centrifuge?
Is this the same as Platelet Rich Plasma?
No, PRP is a concentration of blood platelets that can help stimulate repair of tissue. We do use various advanced platelet preparations to allow cells to grow in culture and help cells engraft once they are re-implanted, but these platelet preparations must be prepared in a lab facility and can’t be created using a bedside centrifuge.
What is the MSC selection procedure?
We use a proprietary lab separation method to select an enriched MSC and HSC population. These are then reinjected in the same surgical procedure.
How are the lab practices audited?
Our practice contracts with outside lab auditing firms. For example, our lab has been inspected 5 times as of this writing.
Where can I find MRI’s before and after treatment?
The Regenexx Medical Provider Information Download contains this information as well as other general information for medical providers (this is a big file, so it may take a few minutes to open using a WiFi connection). Other case reports are often posted on the blog as we obtain follow-up images, click here for the Regenexx blog.
Does the Regenexx procedure and the physician practice use any third party guidelines for lab safety, clinical practice, and patient tracking?
The physicians at our clinic use the ICMS professional guidelines to benchmark their stem cell practice. For more information, on ICMS, click here . Additional information:
1. Stem Cell Lab Practice: We are held to the ICMS lab guidelines. Click here to read the guidelines. Any problems or issues noted by the third party auditor are appropriately addressed.
2. Clinical Practice: Our doctors adhere to the ICMS clinical guidelines for the safe use of autologous stem cell therapy. For more information, click here.
3. Complications Tracking and Safety Monitoring: We utilize the ICMS re-implantation registry as an non-profit third party to track our patients at set time points. The complaints adjudications system for ICMS follows closely the same system used in HHS studies.
We have also published on our complications and safety data (n=227), which is available on-line. Click here to see the study. We are also readying an n=339 2nd stem cell safety paper with significantly more complications end-points in the 2+ year range, which was recently accepted for publication. Both of these studies concern our cultured stem cell procedure, not Regenexx-SD. However, Regenex-SD would use the same cell subset (bone marrow derived MSC’s).
