Actively Recruiting
Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis
Led by Cytori Therapeutics · Updated on 2026-01-22
48
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Cytori Therapeutics
Lead Sponsor
H
Huashan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years inclusive
- Diagnosed with diffuse or localized cutaneous systemic sclerosis according to 2013 ACR/EULAR criteria
- Thickened hand skin with a modified Rodnan skin score from 8 to 35
- Cochin Hand Function Scale score of 20 or higher
- Able to safely undergo liposuction to obtain sufficient adipose tissue
- Voluntary participation with signed informed consent
You will not qualify if you...
- Body mass index less than 17 kg/m²
- Hand skin lesions in atrophic stage unsuitable for injection
- Finger contractures or injection site ulcers preventing safe injection
- Amputation of any finger beyond proximal to distal interphalangeal joints or more than one finger
- Other rheumatic immune diseases affecting hand safety or efficacy evaluation, excluding Sjögren's syndrome
- Active infections or recent antibiotic use within 3 months
- Unstable systemic sclerosis with prior cell therapy
- Chemotherapy or cancer surgery within 5 years
- Abnormal tumor markers indicating tumor risk
- Recent CD20 monoclonal antibody or biologic drug use within 1 year or 3 months respectively
- Previous hand cell injection therapy or systemic cell therapy within 6 months
- Positive HIV, active syphilis, active hepatitis B or C infection
- Safety-related diseases in major organ systems such as uncontrolled diabetes or hypertension
- Abnormal blood counts, liver/kidney function, or coagulation tests beyond specified limits
- Allergy to human albumin, anesthetics, or adipose-derived mesenchymal stem cell components
- Planned surgery with general anesthesia within 3 months
- Participation in other clinical studies within 3 months
- Pregnant, lactating, or unwilling to use contraception during and 6 months after study
- Investigator judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
2
Huashan Hospital Fudan University
Shanghai, China, 200040
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here