Brian Mehling, M.D. and Pavel Yufit, M.D., orthopedic surgeons

AAOS is the world’s largest meeting of orthopedic surgeons, researchers, and allied health professionals. The meeting offers physicians the opportunity to exchange ideas with their colleagues and learn about cutting-edge technology in their field.

Dr. Mehling’s abstract application entitled “Retrospective Chart Review Study of Human Adipose Tissue Derived Mesenchymal Stem Cell Therapy in Subjects with Musculoskeletal Disorders” has been accepted as a Poster presentation for the AAOS 2018 Annual Meeting. This abstract was based on our IRB-approved research study where we analyzed changes in pain and mobility of research subjects with osteoarthritis and rheumatoid arthritis after adipose tissue-derived mesenchymal stem cell (ADSC) therapy.

Please see below for the content of the Poster presentation.

 

AAOS 2018 Annual Meeting

Retrospective Chart Review Study of Human Adipose Tissue Derived Mesenchymal Stem Cell Therapy in Subjects with Musculoskeletal Disorders
Brian M. Mehling
Blue Horizon International, LLC, 214 State Street, Hackensack, New Jersey 07601, USA

Introduction

Musculoskeletal disorders are injuries or pain in the human musculoskeletal system with the consequent loss of mobility, pain and reduction in the quality of life.
Pain is a major healthcare problem affecting individuals with arthritis and musculoskeletal disorders. Pain reduction and mobility improvement are the main outcomes to determine the therapy efficacy of subjects with musculoskeletal disorders.
Stromal vascular fraction of adipose tissue contains mesenchymal stem cells that have the capacity to differentiate into cartilage, bone, muscle, and adipose tissue. Mesenchymal stem cells have been proposed as an optimal regenerative cellular therapeutic for musculoskeletal conditions like osteoarthritis and rheumatoid arthritis.
Adipose tissue can be easily obtained: almost without pain under local anesthesia; without risk of thrombosis or introduction of infection into the bone marrow resulting in sepsis or osteomyelitis.
In the current retrospective study we analyzed changes in pain and mobility of research subjects with osteoarthritis and rheumatoid arthritis after adipose tissue-derived mesenchymal stem cell (ADSC) therapy.

Methods

In the period from 2015 to 2016, 207 subjects underwent the therapy with their own stromal vascular fraction cells at the Malacky Hospital (Bratislava, Slovakia). Affected areas included knee and hip joints (right and left) with arthritis stage I-IV (1 – minor, 4 – severe).
The adipose tissue was removed from the area of abdomen or lower abdomen by gentle aspiration under the local anesthesia – by miniliposuction. The fatty portion diluted with phosphate buffer saline and centrifuged to exclude all hematopoietic cells. The sample is then incubated with collagenase followed by centrifugation and filtration to isolate a stromal vascular fraction containing stem cells.
The chart records are located at the Malacky Hospital and Mehling Orthopedics (Hackensack, NJ). Charts were reviewed and information regarding subjects’ pain and mobility was collected into the data collection form.
This retrospective study was approved by Institutional Review Board of the Institute of Regenerative and Cellular Medicine (IRCM-2017-137).
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). This article does not contain any studies with animal subjects.

Results

Analysis of subjects’ pain sensation showed the following. Ten days after the therapy, pain sensation decreased by 26.8%. Three months after therapy, the number of subjects with a decrease in pain sensation increased to 50.0 %, and six months later, this number was 52.5 %.

The results of changes in subjects’ pain sensation after therapy are shown on Figure 1.

Analysis of subjects’ mobility showed the following. Ten days after the therapy, mobility was improved at 26.0%. Three months after therapy, the number of subjects with improved mobility increased to 43.8%, and six months later this number was 47.4%.

The results of changes in subjects’ mobility after therapy are shown on Figure 2.

Statistical analysis showed that the decrease in subjects’ pain sensation and improvement of subjects’ mobility three and six months after the therapy was statistically significant. The differences in the median values among the treatment groups are greater than the margin of error with a statistically significant difference (P<0,05; Kruskal-Wallis One Way Analysis of Variance on Ranks).

Depending on arthritis stage, subjects were divided into 3 groups. First group included subjects with arthritis stages I, II, and II-III; second group included arthritis stage III; third group included arthritis stage III-IV and IV. Analysis indicated that the therapy was most effective in subjects with arthritis stage III.
Table 1 shows the results of subjects’ pain decrease and mobility improvement in regards to arthritis stage.
Magnetic Resonance Imaging (MRI) was performed before and six months after ADSC therapy. Current retrospective study is underway and we are in the process of analyzing and collecting MRI test results. Preliminary results of MRI examination showed significant regression of bone edema, decrease in intra-articular fluid volume, and increase in cartilage volume six months after ADSC therapy.

Conclusion

Retrospective chart review study showed that intra-articular injection of ADSCs was effective in the improvement of some symptoms related to musculoskeletal conditions. Significant decrease in pain sensation and mobility improvement were observed six months after ADSC therapy. Due to the retrospective nature of the study, we were not able to follow-up with these research subjects and monitor long-term changes in symptoms related to musculoskeletal conditions. In order to further analyze the safety and efficacy of ADSC therapy, further retrospective and prospective studies are warranted.

 

Figure. 1

 

Figure 2

 

Table 1

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