Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis

NCT07360808 | Recruiting DMC

• 1 other identifier: AEGIS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Systemic Sclerosis (SSc); Hand Dysfunction

Keywords

Adipose-Derived Regenerative Cells (ADRCs); Systemic Sclerosis; Hand Function; Raynaud Condition

Outcome Measures

Primary Outcomes (1)

• Change in Cochin Hand Function Scale (CHFS) Score from baseline

  The assessment tool comprises 18 items across five dimensions: kitchen skills (8 items), dressing (2 items), personal hygiene (2 items), work competency (2 items), and other daily living activities (4 items). Each item is scored on a 0-5 scale, where "no difficulty" scores 0 and "inability" scores 5. The total score ranges from 0 to 90 points, with higher scores indicating more severe hand function impairment.

  Screening period (-30 to -1 day), 24 weeks post-treatment (±7 days)

Secondary Outcomes (12)

• Change in Cochin Hand Function Scale (CHFS) Score from baseline

  Screening period (-30 to -1 day), 4 weeks (±3 days) and 12 weeks (±7 days) post-treatment

• Change in modified Rodnan Skin Score (mRSS) from baseline

  Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment

• Change in Raynaud Condition Score (RCS) from baseline

  Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment

• Change in Kapandji Score from baseline

  Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment

• Change in Hand Grip Strength from baseline

  Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment

Other Outcomes (25)

• Vital signs: body temperature

  Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment

• Vital signs: respiration

  Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment

• Vital signs: pulse

  Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment

Study Arms (2)

ADRCs group

EXPERIMENTAL

Device: Autologous ADRCs injection Combined with Standard Therapy

Standard Treatment group

OTHER

Drug: Standard Treatment group

Interventions

Autologous ADRCs injection Combined with Standard Therapy DEVICE

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.

ADRCs group

Standard Treatment group DRUG

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.

Standard Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• Abnormal tumor markers detected during the screening period, and the investigator determines that there is a tumor risk;
• Patients who have received CD20 monoclonal antibody treatment within 1 year before the screening visit, or have used other biologic drugs or taken small molecule targeted drugs within 3 months before the screening visit (excluding those who have maintained a stable dose of ≥ 3 months at the time of enrollment for systemic sclerosis treatment);
• Have received hand cell injection therapy before, or are intolerant to cell therapy, or have received systemic cell injection therapy within 6 months before the screening visit;
• Patients with positive human immunodeficiency virus antibody (anti-HIV-Ab) test results, active syphilis, active hepatitis C (HCV-RNA positive, and hepatitis C antibody positive), hepatitis B (HBsAg positive and HBV-DNA positive) during the screening period;
• There is evidence indicating that the subject currently has possible safety-related diseases in the digestive system, urinary system, cardiovascular system, hematological system, nervous system, mental state, and metabolism, such as poorly controlled diabetes, poorly controlled hypertension, etc.;
• Any of the following laboratory test results during the screening period: ① Abnormal blood routine: hemoglobin \< 80 g/L; white blood cell count \< 3.0 × 10\^9/L; absolute neutrophil count \< 1.2 × 10\^9/L; platelet count \< 100 × 10\^9/L; ② Abnormal liver and kidney function: aspartate transaminase (AST), alanine aminotransferase (ALT), activated partial thromboplastin time (APTT) prolonged \> 1.5 times the upper limit of the reference value; ③ Coagulation dysfunction: prothrombin time (PT) and partial thromboplastin time (APTT) prolonged \> 1.8 times the upper limit of the reference value, or international normalized ratio (INR) \> 2;
• Allergic to any component of human albumin, anesthetic drugs, or human adipose-derived mesenchymal stem cell injection solution, or the investigator determines that the subject is not suitable for enrollment due to a severe allergy history;

Sponsors & Collaborators

• Cytori Therapeutics: lead
• Huashan Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (2)

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Huashan Hospital Fudan University

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 22, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)