{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T14:27:10Z","timestamp":1790519230948,"version":"4.1.0"},"reference-count":35,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2022,6,27]],"date-time":"2022-06-27T00:00:00Z","timestamp":1656288000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100017931","name":"Cytori Therapeutics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017931","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2022,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Hand dysfunction is common in systemic sclerosis (SSc). We undertook this study to evaluate the capacity of autologous adipose\u2010derived regenerative cells (ADRCs) to improve hand function in SSc patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The Scleroderma Treatment with Celution Processed Adipose Derived Regenerative Cells Trial was a prospective, randomized, double\u2010blind trial of ADRCs, in which ADRCs were obtained from patients with SSc by small\u2010volume 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\u2009weeks, 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\u2009weeks. Separate prespecified analyses were performed for patients with diffuse cutaneous SSc (dcSSc) and those with limited cutaneous SSc (lcSSc).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Eighty\u2010eight patients were randomized to receive ADRCs (n\u00a0=\u00a048 [32 patients with dcSSc and 16 with lcSSc]) or placebo (n\u00a0=\u00a040 [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\u2009\u00b1\u2009SD improvement in the CHFS score at 48\u2009weeks 11.0\u2009\u00b1\u200912.5 versus 8.9\u2009\u00b1\u200910.5;\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.299). For patients with dcSSc, the between\u2010group difference in the CHFS at 48\u2009weeks was 6.3 points (nominal\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.069). For the secondary end point, the dcSSc group exhibited a between\u2010group difference of 0.17 points in the HAQ DI (nominal\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.044) at 48\u2009weeks. Of the ADRC\u2010treated 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\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.016). Small\u2010volume adipose tissue harvest and ADRC treatment were well tolerated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/art.42133","type":"journal-article","created":{"date-parts":[[2022,3,31]],"date-time":"2022-03-31T12:47:47Z","timestamp":1648730867000},"page":"1399-1408","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["<scp>Adipose\u2010Derived<\/scp>\n                    Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial"],"prefix":"10.1002","volume":"74","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1412-4453","authenticated-orcid":false,"given":"Dinesh","family":"Khanna","sequence":"first","affiliation":[{"name":"University of Michigan Health  Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Caldron","sequence":"additional","affiliation":[{"name":"Arizona Arthritis &amp; Rheumatology Research  Phoenix"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0411-7519","authenticated-orcid":false,"given":"Richard W.","family":"Martin","sequence":"additional","affiliation":[{"name":"Michigan State University  Grand Rapids"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Kafaja","sequence":"additional","affiliation":[{"name":"University of California  Los Angeles"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2911-6800","authenticated-orcid":false,"given":"Robert","family":"Spiera","sequence":"additional","affiliation":[{"name":"Hospital for Special Surgery  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shadi","family":"Shahouri","sequence":"additional","affiliation":[{"name":"Heartland Research Associates  Wichita, Kansas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ankoor","family":"Shah","sequence":"additional","affiliation":[{"name":"Duke University Medical Center  Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivien","family":"Hsu","sequence":"additional","affiliation":[{"name":"Rutgers University  New Brunswick New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Ervin","sequence":"additional","affiliation":[{"name":"Alliance for Multispecialty Research  Kansas City Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0101-1807","authenticated-orcid":false,"given":"Robert","family":"Simms","sequence":"additional","affiliation":[{"name":"Boston University Medical Center  Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2765-0922","authenticated-orcid":false,"given":"Robyn T.","family":"Domsic","sequence":"additional","affiliation":[{"name":"University of Pittsburgh  Pittsburgh Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Steen","sequence":"additional","affiliation":[{"name":"MedStar Georgetown University Hospital  Washington DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura K.","family":"Hummers","sequence":"additional","affiliation":[{"name":"Johns Hopkins University  Baltimore Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Derk","sequence":"additional","affiliation":[{"name":"University of Pennsylvania  Philadelphia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5070-2535","authenticated-orcid":false,"given":"Maureen","family":"Mayes","sequence":"additional","affiliation":[{"name":"University of Texas Houston McGovern Medical School"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1498-113X","authenticated-orcid":false,"given":"Soumya","family":"Chatterjee","sequence":"additional","affiliation":[{"name":"Cleveland Clinic Orthopedic &amp; 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