About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Subject's body mass index (BMI) < 17 kg/m²;

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

48 Participants

are divided into 2 treatment groups

Group A: ADRCs groupExperimental treatment 1 intervention

Group B: Standard Treatment groupOther 1 intervention

Trial outcomes

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.

Time frame

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

Secondary 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.

Time frame

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

2

Change in modified Rodnan Skin Score (mRSS) from baseline

The researchers evaluated the modified Rodnan Skin Score (mRSS), which assesses skin thickness across 17 different body areas. Each area is rated on a 0-3 scale, with a total score of 51. Higher scores indicate more severe skin fibrosis.

Time frame