Outcomes Registry Data for Regenerative Treatments

How consistently and effectively do any of these regenerative medicine treatments work? A new, impressive outcomes registry covering a broad array of regenerative medicine treatments has just been released and it comes with the most definitive, data-based answers yet to that basic question.

The 20-page report, “An Overview of Regenerative Treatments for Orthopedic Conditions 2021 Outcomes Report,” presents real world, outcomes data collected from 65 physicians at 43 clinics in 25 states.

The patient outcome data covers the following 11 regenerative medicine treatments:

• Adipose (MFAT)
• Bone Marrow
• Hyaluronic Acid
• Perinatal Tissue
• Platelet Lysate
• Platelet Poor Plasma (A2M, PPC)
• Platelet Rich Plasma (PRP)
• Prolotherapy
• Shock Wave Therapy (ESWT/EPAT)
• Sonex
• Tenex

Author, Author!

There has been a paucity of real-world patient outcome data for the vast majority of regenerative medicine treatments. It’s an exciting and innovative field of care, but it has often felt a bit like the wild, wild west.

This report is notable, if for nothing else, for avoiding hype and using accurate and precise nomenclature to refer to various treatments. For example, the words “stem cells” do not appear in this report. Instead, authors referred to living cells with therapeutic value as “regenerative cells” and usually in combination with the term “growth factors.”

As we referred to earlier, 65 physicians from 43 clinics joined in this effort. The organizers, authors and whose signatures grace this report are:

Supporting them are the following members of a scientific advisory board:

• Steve Sampson, DO, founder of Orthohealing Method and The Orthobiologic Institute (TOBI)
• Ken Mautner, MD, Director of Sports Medicine at Emory Healthcare
• William Murrell, MD, Chief Medical Officer for Emirates Healthcare in Dubai

Vision and Mission

This is the inaugural orthobiologics registry report and, as such, the authors took care to articulate a mission, a vision and map out where this emerging practice specialty is heading.

“Our mission”, wrote the authors, “is to empower an international network of physicians, researchers and patients with an outcomes data registry in order to pioneer innovative and effective treatments for patients with orthopedics conditions”.

If successful, and we think this report will demonstrate that they are, the vision is to tether the growth of this dynamic and rapidly evolving orthobiologic practice specialty to real-world safety, efficacy and cost effectiveness data.

One of the ultimate goals of the DataBiologics organization is to help weed out “bad actors” by using real-world patient reported data to demonstrate safety and efficacy of quality physicians.

Background

As Malanga, Bowen, and Rogers wrote in their introduction to this registry report, regenerative medicine is a field notable for its innovative energy to develop alternative treatment options for both acute and chronic orthopedic conditions.

But, importantly, this field requires patient-centered data from a wide array of clinics about the real-world effectiveness, complication rates, and predictability of the different forms of orthobiologic therapies.

And, fundamentally, Malanga, Bowen, and Rogers hope that physicians who read this outcome registry report will “gain an understanding of the progress regenerative medicine has achieved, as well as recognize the dire need for more real-world evidence in order to shape a better orthopedic landscape. Most importantly, we hope this resource will demonstrate our efforts to provide a tool for physicians that improves the quality of patient care and outcomes.”

Scope of the DataBiologic’s Outcome Registry Report

The patient outcomes which are covered in this report include:

• Adverse Events
• FAAM
• HOOS Jr.
• KOOS Jr.
• Neck Disability Index
• Oswestry Disability Index
• Pain Scale (NPRS)
• PHQ-4
• QuickDASH
• VISA-A

And the clinical problems addressed cover spine, large joints, extremities and both acute and chronic conditions.

Data Summary

The report presents standardized reporting data from 9,450 assessments of 3,275 enrolled patients. The average patient age was 54 years, and the average body mass index (BMI) was 26.8.

Most of the patients were treated for knee pain (34%), followed by shoulder (14%), hip (14%), spine (11%) and foot/toes (8%). Also represented were elbow, ankle, wrist/hand and pelvis.

The most common orthobiologic treatment employed in the registry was platelet-rich plasma (PRP) (64%) followed by adipose (17%), bone marrow aspirate stem cell concentrate (BMAC) (12%) and other (7%).

The creators of the report are very clear in stating the data presented in the report is just an overview. More high-quality outcomes data needs to be collected in order to better understand the nuances of treatment effectiveness for specific conditions and patient populations.

PRP Outcomes Data

Seventy-three percent of the patients treated with (PRP) reported a meaningful reduction in pain within 12 months following treatment. Based off published literature, best results with high quality evidence for PRP came from patients treated for lateral epicondylitis or knee osteoarthritis.

There is also strong evidence for PRP in cases of patellar tendinopathy or plantar fasciosis.

Finally, for rotator cuff tendinopathy, osteoarthritis of the hip or high ankle sprains, the outcomes and quality of evidence was “emerging.”

Adipose Tissue Therapy

Seventy percent of the patients treated with adipose tissue therapy reported a meaningful reduction in pain within 12 months following treatment. Based off published literature, best results with strong evidence (a lower bar than “high quality evidence” came from patients treated for knee osteoarthritis.

For rotator cuff and labral tears or osteoarthritis of the hip, the quality of evidence was “emerging.”

Bone Marrow Aspirate

Sixty-one percent of the patients treated with bone marrow aspirate reported a meaningful reduction in pain within 12 months following treatment. Based off published literature, best results with strong evidence were for knee osteoarthritis and low back pain.

For degenerative meniscal tears, hip capsular injury, intervertebral disc repair and patellar tendinopathy, the quality of evidence was “emerging.”

The Future of Regenerative Medicine

As the first outcomes data registry with a meaningful ‘n’ and with standardized data derived from a broad base of clinics around the United States, this is a very important and relevant report.

Our article only touches the surface of what is in this registry report. We urge ALL of our readers, physicians and companies alike, to get a copy of this report and support the efforts of these pioneering physicians.

Going forward, according to the authors, this new DataBiologics platform will allow physicians who employ these therapies to begin patient-reported outcome data collection and contribute to building this important registry. Malanga, Bowen, and Rogers and their registry group are developing the next generation of DataBiologics software which, they hope, will make it easier for physicians to collect and report their outcome data.

If you want to be part of the DataBiologics future, please contact:  info@databiologics.com.