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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
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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.
Systemic sclerosis (SSc) often preferentially affects the hands, leading to skin thickening, limited mobility, pain, and even digital ulcers, severely impairing hand function and quality of life in patients. This prospective, randomized, multicenter, superiority-designed clinical study aims to evaluate the safety and efficacy of autologous adipose-derived regenerative cells (ADRCs) prepared using the Celution 800/GP System and the Celution 805 for improving hand dysfunction in patients with systemic sclerosis.
The study plans to enroll 48 eligible patients, randomly assigned to two groups. For the ADRCs group, at least 180 mL of autologous adipose tissue was obtained via liposuction. The Celution 800/GP system and Celution 805 were used to wash, separate, and enrich the ADRCs. These were then adjusted to a volume of 10 mL using Lactated Ringer's solution (divided into 10 syringes of 1 mL each) and injected into specific sites on each finger of both hands (both sides of the metacarpophalangeal joint of the thumb and both sides of the proximal interphalangeal joints of the other fingers). The control group received standard treatment guided by the "Diagnosis and Treatment Guidelines for Systemic Sclerosis." Patients were randomly assigned to the two groups in a 1:1 ratio. Participants were followed up multiple times within 4 weeks, 12 weeks, and 24 weeks post-procedure.
The primary endpoint was the change from baseline in the Cochin Hand Function Scale (CHFS) score at 24 weeks. Secondary endpoints included changes from baseline in the CHFS score at 4 and 12 weeks; the modified Rodnan skin score at 4, 12, and 24 weeks; Raynaud's Condition Score; Kapandji score; hand grip strength/pinch strength; Systemic Sclerosis Health Assessment Questionnaire (SHAQ) score; pain Visual Analogue Scale (VAS) score; and digital ulcer clinical assessment scale score at the respective timepoints. Additionally, changes from baseline in hand skin ultrasound examination and nailfold capillaroscopy results at 24 weeks were assessed. Performance evaluation of the Celution800/GP system and Celution805, monitoring of safety indicators, and device deficiencies were also included.
Statistical analysis followed standard principles using SAS software (version 9.4). Efficacy analyses were performed using data from both the Full Analysis Set and the Per-Protocol Set, while safety analyses used the Safety Analysis Set.
This study focuses on the safety and efficacy of autologous ADRCs in treating hand dysfunction in systemic sclerosis, offering a new direction for improving hand dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADRCs group | Experimental |
| |
| Standard Treatment group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NanFang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| 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. |
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| 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 | 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. | 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 | The evaluation was conducted by the subjects. The Raynaud Condition Score (RCS) assesses the degree of sensory difficulty in the patient's hands. The RCS is a self-assessment of daily Raynaud Phenomenon (RP) activity, including the daily cumulative frequency, duration, severity, and impact of RP episodes. It is evaluated using a 0-10 rating scale via standardized scoring rules. Subjects record the number of RP episodes per day and the duration of each episode (in minutes), and complete the Raynaud Condition Score (RCS). The researchers calculate and record the average score of the subjects' Raynaud values. | 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 | The evaluation is conducted by the researchers. Based on the position where the thumb tip can be reached when each finger is fully extended, the following 10 areas are assessed: ① the radial side of the middle joint of the index finger, ② the radial side of the distal joint of the index finger, ③ the tip of the index finger, ④ the tip of the middle finger, ⑤ the tip of the ring finger, ⑥ the tip of the little finger, ⑦ the radial side of the distal interphalangeal joint of the little finger, ⑧ the proximal end of the little finger (near the nail), ⑨ the radial side of the metacarpophalangeal joint of the little finger, ⑩ the distal palmar line. These 10 areas represent scores of 1 to 10 respectively. | 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 | The evaluation is conducted by the researchers. Subject position: Sit quietly in a upright position, with the shoulder joint at 0 degrees, the elbow at 90 degrees, the upper arm flat against the chest, the forearm in a neutral position, and the wrist at 30 degrees of extension. Instruct the subjects to exert their maximum effort to measure the grip strength of both hands. Repeat the measurement three times, with a rest period for the subjects between each measurement to eliminate test fatigue. Take the average of the three test results as the final test result. | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Change in Hand Pinch Strength from baseline | The evaluation is conducted by the researchers. Subject position: Sit quietly in a upright position, with the shoulder joint at 0 degrees, the elbow at 90 degrees, the upper arm flat against the chest, the forearm in a neutral position, and the wrist at 30 degrees of extension. Instruct the subjects to exert their maximum effort to measure the pinch force of both hands. Repeat the measurement three times, with a rest period for the subjects between each measurement to eliminate test fatigue. Take the average of the three test results as the final test result. | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Change in Hand Skin Ultrasound from baseline | The evaluation was conducted by the researchers. The thickness of the skin on the hands was measured using ultrasound. | Screening period (-30 to -1 day) and 24 weeks (±7 days) post-treatment |
| Change in Nailfold Microcirculation from baseline | The evaluation was conducted by the researchers. The nailfold microcirculation examination assesses the severity of microvascular lesions in the fingers of both hands (excluding the thumbs). | Screening period (-30 to -1 day) and 24 weeks (±7 days) post-treatment |
| Change in Systemic Sclerosis Health Assessment Questionnaire (SHAQ) Score from baseline | The evaluation is conducted by the subjects. SHAQ consists of two parts: ① The standard HAQ section (8 types of daily activities), which assesses the ability to perform daily activities and the tools and assistance required for completing daily activities; ② Specific additional questions for systemic sclerosis include 5 visual analogue scales (VAS), covering the impact of Raynaud's phenomenon; gastrointestinal symptoms; respiratory system symptoms; skin tightness; and overall assessment of disease severity. | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Change in Pain Visual Analogue Scale (VAS) Score from baseline | The evaluation is conducted by the subjects.The evaluation is conducted by the subjects. The subjects mark the corresponding position on this line to represent the intensity of the pain they experienced at that moment. The distance from the starting point to the marking point is measured to obtain the pain score. The higher the score, the more intense the pain. | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Change in Digital Ulcer Clinical Assessment Scale Score (HDISS-DU) from baseline | The evaluation was conducted by blind assessors. The impact of scleroderma-related fingertip ulcers on hand function was assessed using the HDISS-DU scale. Twenty-four questions were posed over a 7-day observation period, with answer scores ranging from 1 to 6. A score of 1 indicated "can, without difficulty", while a score of 6 indicated "cannot". A score of 5 indicated "almost impossible" or "can only be completed with the unaffected hand that is not ulcerated". | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Equipment performance evaluation | Incidence of breakage of connecting components, loosening and falling off of components, and electric leakage of the control system in the Celution800/GP system (%) | 0 day |
| Vital signs: pulse | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Vital signs: blood pressure | systolic and diastolic | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Red Blood Cell (RBC) Count | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: White Blood Cell (WBC) Count | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Platelets (PLT) Count | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Hemoglobin (HB) Concentration | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Neutrophil (NEUT) Percentage | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Urinary Protein (PRO) | Qualitative result (＋/-) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Urinary Glucose (GLU) | Qualitative result (＋/-) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Urinary White Blood Cells (WBC) Count | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Urinary Red Blood Cells (RBC) Count | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Aspartate Aminotransferase (AST) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Alanine Aminotransferase (ALT) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Creatinine (Cr) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Blood Urea Nitrogen (BUN)/Urea | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Activated Partial Thromboplastin Time (APTT) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Prothrombin Time (PT) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Fibrinogen (FIB) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Thrombin Time (TT) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: Fibrin (Fibrinogen) Degradation Products (FDP) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Laboratory tests: D-Dimer (D-D) | Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment |
| Incidence of Adverse Events, Incidence of Serious Adverse Events | From Day 0 through the completion of follow-up.Each individual participant will undergo a 24 weeks follow-up period, and it is anticipated that all follow-up assessments will be completed by December 31, 2027. |
| Device defects: Incidence Rate of Medical Device Malfunctions | 0 day |
| Huashan Hospital Fudan University | Recruiting | Shanghai | 200040 | China |
|
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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