Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction … (NCT07360808) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis
China48 participantsStarted 2025-12-31
Plain-language summary
This prospective, randomized, blinded, multicenter clinical study aims to evaluate the safety and efficacy of autologous adipose-derived regenerative cells (ADRCs) in improving hand dysfunction in patients with systemic sclerosis (SSc). The study plans to enroll 48 eligible patients, randomly assigned to two groups. The experimental group will receive ADRCs, prepared from the Celution system, which is injected into specific sites on each finger of both hands. The control group will receive standard care according to established treatment guidelines. The primary endpoint is the change from baseline in the Cochin Hand Function Scale (CHFS) score at 24 weeks. Secondary endpoints include assessments of skin thickness, Raynaud phenomenon, hand strength, quality of life, pain, and other measures at various time points. Safety and device performance will be monitored throughout the study. This investigation seeks to explore a new potential therapeutic direction for managing hand dysfunction in systemic sclerosis.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 18-70 years old (inclusive), gender not restricted;
✓. According to the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) systemic sclerosis (SSc) diagnostic criteria, diagnosed as diffuse cutaneous type or localized cutaneous type;
✓. Thickened hand skin, modified Rodnan skin score ≥ 8 points and ≤ 35 points;
✓. Cochin Hand Function Scale (CHFS) ≥ 20 (total score 90), with or without skin ulcers;
✓. Capable of safely undergoing liposuction to obtain sufficient adipose tissue (the preferred fat extraction sites are the abdomen, followed by the lateral abdomen, inner and outer thighs, posterior thighs, and anterior thighs; multiple sites can be selected for liposuction to obtain sufficient adipose tissue);
✓. Voluntary participation in this clinical trial and signing the informed consent form by the subject.
Exclusion criteria
✕. Subject's body mass index (BMI) \< 17 kg/m\^2;
✕. Hand skin lesions are in the atrophic stage, and the investigator determines that they are not suitable for hand drug injection;
What they're measuring
1
Change in Cochin Hand Function Scale (CHFS) Score from baseline
Timeframe: Screening period (-30 to -1 day), 24 weeks post-treatment (±7 days)
✕. Any finger contracture or injection site ulcer that makes it unsafe to complete the injection;
✕. Any proximal to distal interphalangeal joint amputation of any finger, or amputation of more than one finger;
✕. Concurrent other rheumatic immune diseases, such as RA, SLE, dermatomyositis, etc. (existing rheumatic immune diseases that do not affect the safety and efficacy evaluation of the hand and do not affect the safety of the hand and efficacy evaluation, excluding Sjögren's syndrome);
✕. Active infectious diseases or patients who have used antibiotics within 3 months before the screening visit due to active infectious diseases;
✕. Patients with unstable systemic sclerosis who have received cell therapy before the screening visit;
✕. Patients who have undergone chemotherapy or resection of malignant cancer within 5 years before the screening visit;