Trial reportArthritis & rheumatology (Hoboken, N.J.)2022
Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial.
Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Efficacy and safety of mesenchymal stromal cell transplantation in the treatment of autoimmune and rheumatic immune diseases: a systematic review and meta-analysis of randomized controlled trials.Stem cell research & therapy · 2025Pooled it
- Trial
- Emerging Cell-Based Therapies for Systemic Sclerosis: From Stem Cells to CAR-T Cells.Current issues in molecular biology · 2026Review
- Comparative Efficacy of Autologous Hematopoietic and Mesenchymal Stem Cell Transplantation in Patients with Systemic Sclerosis: A Systematic Review.Journal of clinical medicine · 2025Review
- [S2k guidelines on diagnostics and treatment of systemic sclerosis : Full version].Zeitschrift fur Rheumatologie · 2025Review
- Diagnostics, Efficacy, and Safety of Immunomodulatory and Anti-Fibrotic Treatment for Interstitial Lung Disease Associated with Systemic Scleroderma (SSc-ILD).Diagnostics (Basel, Switzerland) · 2025Review
- Stem cell therapy in systemic sclerosis.Clinical rheumatology · 2025Review
- Maximizing the Longevity and Volume Retention of Fat Grafts: Advances in Clinical Practice.Cureus · 2025Review
- Adipose-derived stem cells in immune-related skin disease: a review of current research and underlying mechanisms.Stem cell research & therapy · 2024Review
- Psychological features of systemic sclerosis: results from an observational study.Frontiers in medicine · 2024Article
- Mesenchymal Stem/Stromal Cell-Based Therapies in Systemic Rheumatic Disease: From Challenges to New Approaches for Overcoming Restrictions.International journal of molecular sciences · 2023Review
- Improving outcomes in scleroderma: recent progress of cell-based therapies.Rheumatology (Oxford, England) · 2023Review
- Adipose Tissue and Adipose-Tissue-Derived Cell Therapies for the Treatment of the Face and Hands of Patients Suffering from Systemic Sclerosis.Biomedicines · 2023Review
- Immune cell dysregulation as a mediator of fibrosis in systemic sclerosis.Nature reviews. Rheumatology · 2022Review
- Review
Corrections and comments
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Authors and funding
20 authors at 18 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveHand 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.
methodsThe 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).
resultsEighty-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.
conclusionWhile 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.