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Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis
Sponsor: Cytori Therapeutics
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.
Official title: Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis: A Prospective, Randomized, Multicenter Superiority Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-12-31
Completion Date
2027-12-31
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
Autologous ADRCs injection Combined with Standard Therapy
Liposuction harvests ≥180 mL adipose tissue from the subject's abdomen/thighs or other suitable sites. Tissue is cleaned/separated via Celution 800/GP to obtain ADRCs, whose total volume is adjusted to 10 mL with lactated Ringer's solution. On treatment day, single retrograde injection is given to each finger of both hands (1 mL total per finger). Both thumbs: Injection sites on both sides of metacarpophalangeal joint. Insert 25G sharp needle from joint to thumb's distal end; switch to 25G blunt needle for subcutaneous retrograde injection (distal→proximal). 0.5 mL per side, total 1 mL. Other fingers: Injection sites on both sides of proximal interphalangeal joint (palmar-dorsal skin junction). Insert 25G sharp needle toward finger's proximal/distal ends; switch to 25G blunt needle for injection (distal→joint, proximal→joint). 0.25 mL per direction per side (0.5 mL/side), total 1 mL ADRCs per finger.
Standard Treatment group
The standard treatment refers to the routine treatment plan formulated by researchers for subjects in accordance with the "Diagnosis and Treatment Standards for Systemic Sclerosis" and based on the specific conditions of the patients.
Locations (2)
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Huashan Hospital Fudan University
Shanghai, China