Information For Physicians
Regenexx Procedure: Information for Health Care Providers
Stem cells are heavily advertised all over the Internet. RSI recognizes 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). They are isolated in the lab from a bone marrow aspirate.
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. 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.
Is this the same as BMAC or a bone marrow concentrate prepared at the bedside in a centrifuge?
No. BMAC is a very dilute stem cell mixture which contains mostly stem cells that help to make new blood products. Only about 1 in 100,000 to 1 in 500,000 of these cells is a stem cell capable of orthopedic tissue repair. RSI first strated experimenting with a more sophisticated form of lab prepared BMAC in 2005 and abandoned it’s use by 2006 when we found it significantly less capable of demonstrating MRI changes indicating repair of orthopedic tissues.
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 adhesion and multiple culture passages to select a pure MSC population. These are then culture expanded to achieve a clinically relevant number of cells.
How are the cell grown?
The cells are grown using the growth factors isolated from the patient’s blood platelets (platelet lysate). The cells are first plated from the bone marrow in a colony forming monolayer culture. Once colonies form, the cells are transferred to monolayer expansion culture and continually isolated and culture expanded to increasing numbers.
Where are the cells grown?
Our medical practice grows cells in a state of the art, positive pressure cell culture lab. Cell biologists minimally manipulate cells in laminar flow hoods. The lab is located in Broomfield, Colorado.
How are the lab practices audited?
Our practice contracts with Reglera, a nationally recognized leader in quality standards. We initiate regular site visits by Reglera to check our facility, lab practices, the work of our cell biologists, and equipment.
What are average yields?
A yield is how many cells are produced at the end of the culture period. The average yield for our patients is between 5-50 million cells with significant biologic variability between patients (meaning some patients expand to significantly more or less than these averages).
What is the cell phenotype being produced by the procedure?
Cell phenotype means the exact type of cell. With adult stem cells, this is usually defined as the types of markers these cells exhibit on their surfaces. The most commonly reported markers to determine stem cell phenotype are CD or “Cluster of Differentiation”. The CD cell marker profile as tested by the University of Colorado Immunology Department is: CD14-, CD29+, CD31-, CD44+, CD59+, CD90+, CD106 weak +, CD166+, CD73+, CD105+. Further analysis of multiple cell lines using our own in lab flow cytometer is illustrated below:
Where can I find MRI’s before and after treatment?
The Regenexx Medical Provider Information June 2010 contains this information as well as other general information for medical providers. Other case reports are often posted on the blog as we obtain follow-up images, click here for the Regenexx blog.
Do you have any large scale outcomes data?
Yes, we are just beginning to report long-term, larger scale outcome data. Knee outcome data can found at this link. We will be updating this data during the summer of 2010 for various procedures.
Does the Regenexx procedure and the physician practice use any third party guidelines for lab safety, clinical practice, and patient tracking?
The physicians at the Regenexx clinic use the ICMS professional guidelines to benchmark their stem cell practice. For more information, on ICMS, click here . We follow these professional guidelines:
1. Stem Cell Lab Practice: We undergo approximately bi-annual audits through Reglera, a nationally known lab best practices organization. We are held to the ICMS lab guidelines. Click here to read the guidelines. Any problems or issues noted by Reglera are appropriately addressed.
2. Clinical Practice: The doctors at Regenexx 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 safety paper with significantly more complications end-points in the 2+ year range, which should be submitted for publication in summer of 2010.
