Preliminary Communication

Amniotic dehydrated cell and protein concentrate versus corticosteroid in knee osteoarthritis: preliminary findings

*Author for correspondence: Tel.: +1 404 778 8081;

E-mail Address: oolufad@emory.edu

Department of Orthopedics, Emory University, Atlanta, GA 30329, USA

Department of Physical Medicine & Rehabilitation, Emory University, Atlanta, GA 30307, USA

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Giorgio Negron

https://orcid.org/0000-0002-4007-1714

Department of Physical Medicine & Rehabilitation, Emory University, Atlanta, GA 30307, USA

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William Berrigan

https://orcid.org/0000-0002-0480-2372

Department of Orthopedics, Emory University, Atlanta, GA 30329, USA

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Benjamin Sirutis

https://orcid.org/0000-0003-2710-9041

Department of Physical Medicine & Rehabilitation, Emory University, Atlanta, GA 30307, USA

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Jeremy Whitley

Department of Orthopedics, Emory University, Atlanta, GA 30329, USA

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Kirk Easley

https://orcid.org/0000-0003-4419-2617

Department of Biostatistics & Bioinformatics, Rollins School of Public Health Emory University, Atlanta, GA 30329, USA

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Yunyun Chen

https://orcid.org/0000-0001-9818-6824

Department of Biostatistics & Bioinformatics, Rollins School of Public Health Emory University, Atlanta, GA 30329, USA

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Kenneth Mautner

https://orcid.org/0000-0001-8458-0126

Department of Orthopedics, Emory University, Atlanta, GA 30329, USA

Department of Physical Medicine & Rehabilitation, Emory University, Atlanta, GA 30307, USA

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Published Online:19 May 2022https://doi.org/10.2217/rme-2022-0005

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Abstract

Objectives: The purpose is to report preliminary data on clinical response to dehydrated cell and protein concentrate (dCPC) versus corticosteroid (CSI). Design: A single-site prospective, randomized controlled single-blinded trial of patients with knee osteoarthritis. Methods: Pain and function were assessed using a visual analog scale (VAS), the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Emory Quality of Life (EQOL) measure at 1, 2, 3, 6, 9 and 12 months. Results: 51 patients were enrolled at the time of analysis (27 dCPC, 24 CSI). Both groups demonstrated improvement on the VAS, KOOS and EQOL. Largest differences were observed at 2 (p = 0.05), 3 (p = 0.012) and 6 months (p < 0.001) with a decrease of 1.66 in VAS at 6 months for dCPC (95% CI: -2.67 to -0.65) and 1.34 (95% CI: -2.37 to -0.3) for CSI. Time-averaged measures showed no difference between groups (p = 0.20). Limited data at 9 and 12 months trended toward improvement in the dCPC group. Conclusion: dCPC products may be used as a treatment for knee osteoarthritis. Larger trials are warranted.

Clinical Trial Registration: NCT03710005 (ClinicalTrials.gov)

Plain language summary

The purpose of this study was to discuss preliminary data from a clinical trial comparing a single injection of an amniotic-derived tissue product (dehydrated cell and protein concentrate [dCPC]) to corticosteroid for the treatment of knee osteoarthritis. The study took place at a single institution. 51 patients were enrolled at the time of analysis (27 dCPC, 24 corticosteroid). Both groups demonstrated improvement in pain and function 6 months after treatment. There was a larger improvement in the amniotic-derived tissue product group, but this did not reach a level of statistical significance. There were limited data beyond 6 months, but this trended toward a continued improvement in the amniotic-derived tissue product group. Findings suggest that these amniotic derived tissue products may be used as a treatment for knee osteoarthritis, but larger studies are needed.

Tweetable abstract

In a preliminary analysis of an RCT comparing amniotic dCPC to corticosteroid injection for knee osteoarthritis, researchers found that dCPC may be a viable treatment option. This warrants further study.

The study was registered on ClinicalTrials.gov with registration number NCT03710005.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 17, No. 7

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History

Received 9 January 2022

Accepted 21 April 2022

Published online 19 May 2022

Published in print July 2022

Information

Keywords

Financial & competing interests disclosure

Stimlabs donated Ascent vials in kind, and the department received monetary support toward research. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

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