Wednesday, June 19, 2019

Wisdom Wednesday: Research Study on the Effectiveness of Stem Cell Injections

Between June 2014 and February 2017, data from 233 patients with knee osteoarthritis treated with BMAC injection at a single center were retrospectively evaluated. Only patients with idiopathic osteoarthritis were included. Exclusion criteria were post-traumatic osteoarthritis, previous knee surgery, age less than 50 years old or more than 85 years old, active infection, uncontrolled diabetes mellitus, rheumatological or other systemic disease, malignancy, or treatment with immunosuppressive drugs. Bone marrow from the iliac crest was aspirated/concentrated with a standardized technique using a single-spin manual method. Patients were evaluated before and after the procedure, using the numeric pain scale (NPS) and Oxford knee score (OKS). Mean follow-up period was 11 months, range (6e30 months).

A total of 121 of 233 patients had completed data as previously defined and were included in the statistical analysis. There were 85 females and 36 males, with mean age 70 years (range 50e85). Compared to baseline, the mean NPS decreased from 8.33 to 4.49 (p 0.001) and the mean OKS increased from 20.20 to 32.29 (P 0.001) at final follow-up. There were no complications.

A single intra-articular injection of BMAC is a safe and reliable procedure that results in clinical improvement of knee OA.

My Take:
This is just the summary of the full article which Apex was kind enough to send to me. The published study listed any conflicts of interest, financial support and most importantly limitations of the study. The study was self-supported by the clinic in Greece that performed all the procedures without any outside financial support.

There were significant limitations. The first and foremost was that there was no control group. The second was that the study was retrospective, not allowing follow-up at regular intervals. Follow-up varied case by case. Third, the study only involved advanced cases of osteoarthritis (grade 3 and 4). The authors believe this is because the culture of Greece leans toward having several orthopedic interventions and only seeking this type of care when joint replacement has been recommended. There is no data on how effective this procedure might be with mild cases of osteoarthritis. Fourth, the authors believe there is a bias toward their procedure from “word of mouth” from former patients toward prospective patients.

Last, there was no laboratory analysis of the variable components of the BMAC concentrate. They take 60ml of fluid from the bone marrow, then centrifuge the aspirate carefully and extract 20ml of the “buffy coat”. This is the fluid between the plasma and packed cells. It contains variable amounts of serum and packed red blood cells, along with hematopoietic stem cells, platelets, growth factors (GFs), cytokines and chemokines. The BMAC is full of good stuff but undoubtedly varies from procedure to procedure.

Bottom Line:
Despite all the limitations, the results from just one injection of BMAC on advanced osteoarthritis are remarkable. As a patient suffering from early osteoarthritis of the hip, I would much prefer single intra-articular injection of BMAC to any surgical intervention. I would be open to repeat the procedure as needed rather than face a hip joint replacement. The fact that 86% of the patients would recommend the therapy and there were no reported side effects speaks volumes. Watch for this procedure to be available in the United States.

Source: June 14, 2019 Apex Biologix

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