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Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial.

Publication ,  Journal Article
Khanna, D; Caldron, P; Martin, RW; Kafaja, S; Spiera, R; Shahouri, S; Shah, A; Hsu, V; Ervin, J; Simms, R; Domsic, RT; Steen, V; Hummers, LK ...
Published in: Arthritis Rheumatol
August 2022

OBJECTIVE: Hand dysfunction is common in systemic sclerosis (SSc). We undertook this study to evaluate the capacity of autologous adipose-derived regenerative cells (ADRCs) to improve hand function in SSc patients. METHODS: The Scleroderma Treatment with Celution Processed Adipose Derived Regenerative Cells Trial was a prospective, randomized, double-blind trial of ADRCs, in which ADRCs were obtained from patients with SSc by small-volume adipose tissue harvest, and the fingers of each patient were injected with ADRCs. The primary end point was change in hand function at 24 and 48 weeks, assessed using the Cochin Hand Function Scale (CHFS). One of the secondary end points included the change in Health Assessment Questionnaire disability index (HAQ DI) at 48 weeks. Separate prespecified analyses were performed for patients with diffuse cutaneous SSc (dcSSc) and those with limited cutaneous SSc (lcSSc). RESULTS: Eighty-eight patients were randomized to receive ADRCs (n = 48 [32 patients with dcSSc and 16 with lcSSc]) or placebo (n = 40 [19 patients with dcSSc and 21 with lcSSc]). Change in hand function according to CHFS score was numerically higher for the ADRC group compared to the placebo group but did not achieve statistical significance (mean ± SD improvement in the CHFS score at 48 weeks 11.0 ± 12.5 versus 8.9 ± 10.5; P = 0.299). For patients with dcSSc, the between-group difference in the CHFS at 48 weeks was 6.3 points (nominal P = 0.069). For the secondary end point, the dcSSc group exhibited a between-group difference of 0.17 points in the HAQ DI (nominal P = 0.044) at 48 weeks. Of the ADRC-treated patients with dcSSc, 52% reported improvement greater than the minimum clinically important difference for both CHFS and HAQ DI compared to 16% in the placebo group (nominal P = 0.016). Small-volume adipose tissue harvest and ADRC treatment were well tolerated. CONCLUSION: While the primary end point of this trial was not achieved, efficacy trends were observed in patients with dcSSc. Adipose tissue harvest and ADRC injection were demonstrated to be feasible. Further clinical trials of this intervention in the setting of dcSSc are warranted.

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Published In

Arthritis Rheumatol

DOI

EISSN

2326-5205

Publication Date

August 2022

Volume

74

Issue

8

Start / End Page

1399 / 1408

Location

United States

Related Subject Headings

  • Scleroderma, Systemic
  • Scleroderma, Diffuse
  • Prospective Studies
  • Humans
  • Hand
  • Cell Transplantation
  • 3204 Immunology
  • 3202 Clinical sciences
 

Citation

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Khanna, D., Caldron, P., Martin, R. W., Kafaja, S., Spiera, R., Shahouri, S., … Furst, D. E. (2022). Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial. Arthritis Rheumatol, 74(8), 1399–1408. https://doi.org/10.1002/art.42133
Khanna, Dinesh, Paul Caldron, Richard W. Martin, Suzanne Kafaja, Robert Spiera, Shadi Shahouri, Ankoor Shah, et al. “Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial.Arthritis Rheumatol 74, no. 8 (August 2022): 1399–1408. https://doi.org/10.1002/art.42133.
Khanna D, Caldron P, Martin RW, Kafaja S, Spiera R, Shahouri S, et al. Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial. Arthritis Rheumatol. 2022 Aug;74(8):1399–408.
Khanna, Dinesh, et al. “Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial.Arthritis Rheumatol, vol. 74, no. 8, Aug. 2022, pp. 1399–408. Pubmed, doi:10.1002/art.42133.
Khanna D, Caldron P, Martin RW, Kafaja S, Spiera R, Shahouri S, Shah A, Hsu V, Ervin J, Simms R, Domsic RT, Steen V, Hummers LK, Derk C, Mayes M, Chatterjee S, Varga J, Kesten S, Fraser JK, Furst DE. Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial. Arthritis Rheumatol. 2022 Aug;74(8):1399–1408.
Journal cover image

Published In

Arthritis Rheumatol

DOI

EISSN

2326-5205

Publication Date

August 2022

Volume

74

Issue

8

Start / End Page

1399 / 1408

Location

United States

Related Subject Headings

  • Scleroderma, Systemic
  • Scleroderma, Diffuse
  • Prospective Studies
  • Humans
  • Hand
  • Cell Transplantation
  • 3204 Immunology
  • 3202 Clinical sciences