Autologous fat‑derived regenerative cell injections for hand problems in systemic sclerosis

Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis: A Prospective, Randomized, Multicenter Superiority Trial

This treatment will try injecting a patient's own fat-derived regenerative cells into the fingers to see if it improves hand function in adults with systemic sclerosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Cytori Therapeutics (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT07360808 on ClinicalTrials.gov

What this trial studies

This is a randomized, blinded, multicenter study enrolling 48 patients who will be assigned 1:1 to receive autologous adipose-derived regenerative cells (ADRCs) processed with the Celution systems plus standard care or to receive standard care alone. ADRCs are obtained by liposuction (at least ~180 mL of fat), processed and adjusted to 10 mL then injected into specified sites on each finger; the control arm follows guideline-directed treatment. The primary outcome is change in the Cochin Hand Function Scale (CHFS) at 24 weeks with additional assessments of skin thickness, Raynaud symptoms, strength, pain, quality of life, and safety at earlier and later time points. Device performance and adverse events are monitored throughout follow-up visits at about 4, 12, and 24 weeks.

Who should consider this trial

Good fit: Adults aged 18–70 with a diagnosis of systemic sclerosis (diffuse or limited), moderate hand dysfunction (CHFS ≥ 20) and skin thickening (modified Rodnan skin score 8–35) who can safely undergo liposuction are the intended candidates.

Not a fit: People with very low BMI (<17 kg/m2), atrophic hand skin lesions, major contraindications to liposuction, or who do not meet the CHFS or skin score thresholds are unlikely to qualify or to receive benefit from this procedure.

Why it matters

Potential benefit: If effective, this approach could improve hand function, reduce pain and stiffness, and improve quality of life for people with systemic sclerosis affecting the hands.

How similar studies have performed: Small case series and early-phase studies of autologous adipose-derived cells in scleroderma have shown promising signals for ulcer healing and hand function, but randomized controlled evidence is still limited.

Eligibility criteria

Inclusion Criteria:

1. Age 18-70 years old (inclusive), gender not restricted;
2. 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;
3. Thickened hand skin, modified Rodnan skin score ≥ 8 points and ≤ 35 points;
4. Cochin Hand Function Scale (CHFS) ≥ 20 (total score 90), with or without skin ulcers;
5. 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);
6. Voluntary participation in this clinical trial and signing the informed consent form by the subject.

Exclusion Criteria:

1. Subject's body mass index (BMI) \< 17 kg/m\^2;
2. Hand skin lesions are in the atrophic stage, and the investigator determines that they are not suitable for hand drug injection;
3. Any finger contracture or injection site ulcer that makes it unsafe to complete the injection;
4. Any proximal to distal interphalangeal joint amputation of any finger, or amputation of more than one finger;
5. 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);
6. Active infectious diseases or patients who have used antibiotics within 3 months before the screening visit due to active infectious diseases;
7. Patients with unstable systemic sclerosis who have received cell therapy before the screening visit;
8. Patients who have undergone chemotherapy or resection of malignant cancer within 5 years before the screening visit;
9. Abnormal tumor markers detected during the screening period, and the investigator determines that there is a tumor risk;
10. 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);
11. 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;
12. 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;
13. 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.;
14. 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;
15. 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;
16. Patients whose screening visit is within 3 months before the general anesthesia surgery planned during the study period;
17. Patients who have participated in other clinical studies within 3 months before the screening visit, or are currently participating in other clinical studies;
18. Pregnant women, lactating women, those with positive pregnancy test results, or those who do not agree to use effective contraceptive measures during the study period and within 6 months after the trial;
19. Patients judged by the investigator to be unsuitable to participate in this study.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• NanFang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Huashan Hospital Fudan University — Shanghai, China (Recruiting)

Conditions Systemic Sclerosis; Hand Dysfunction; Adipose-Derived Regenerative Cells; Hand Function; Raynaud Condition