Systemic Sclerosis (SSc)AEGISNCT07360808
Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis
A study testing Autologous ADRCs injection Combined with Standard Therapy and Standard Treatment group in people with Systemic Sclerosis (SSc) and Hand Dysfunction, run by Cytori Therapeutics at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Sclerosis (SSc), Hand Dysfunction
- What is being tested?
- Autologous ADRCs injection Combined with Standard Therapy and Standard Treatment group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- 31 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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;
- Patients whose screening visit is within 3 months before the general anesthesia surgery planned during the study period;
- Patients who have participated in other clinical studies within 3 months before the screening visit, or are currently participating in other clinical studies;
- 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;
- Patients judged by the investigator to be unsuitable to participate in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
NanFang Hospital of Southern Medical University, 020-62787238, nfyyec@163.com
- Recruiting
Huashan Hospital Fudan University
Shanghai, 200040
Huashan Hospital Fudan University, 021-52888045, licaihong199505@163.com
About this study
Official title: Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis: A Prospective, Randomized, Multicenter Superiority 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.
Read the detailed description
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.
- Conditions
- Systemic Sclerosis (SSc), Hand Dysfunction
- Being tested
- Autologous ADRCs injection Combined with Standard Therapy, Standard Treatment group
- Keywords
- Adipose-Derived Regenerative Cells (ADRCs), Systemic Sclerosis, Hand Function, Raynaud Condition
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous ADRCs injection Combined with Standard TherapyDevice
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 groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ADRCs group | Experimental | Not described Receives: Device: Autologous ADRCs injection Combined with Standard Therapy |
| Standard Treatment group | Other | Not described Receives: Drug: Standard Treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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 (%)
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start31 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360808
- Sponsor's protocol ID
- AEGIS
- Acronym
- AEGIS
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis: A Prospective, Randomized, Multicenter Superiority Trial
- ClinicalTrials.gov ID
- NCT07360808
- Acronym / sponsor ID
- AEGIS / AEGIS
- Conditions
- Systemic Sclerosis (SSc), Hand Dysfunction
- Keywords
- Adipose-Derived Regenerative Cells (ADRCs), Systemic Sclerosis, Hand Function, Raynaud Condition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital, Nanfang Hospital, Southern Medical University
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADRCs group | Experimental | Device: Autologous ADRCs injection Combined with Standard Therapy |
| Standard Treatment group | Other | Drug: Standard Treatment group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (19 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous ADRCs injection Combined with Standard TherapyLiposuction 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. | Device | ADRCs group |
| Standard Treatment groupThe 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. | Drug | Standard Treatment group |
Primary outcome
Change in Cochin Hand Function Scale (CHFS) Score from baseline
Time frame: Screening period (-30 to -1 day), 24 weeks post-treatment (±7 days)
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.
12 secondary outcomes
Change in Cochin Hand Function Scale (CHFS) Score from baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Screening period (-30 to -1 day) and 24 weeks (±7 days) post-treatment
Change in Nailfold Microcirculation from baseline
Time frame: Screening period (-30 to -1 day) and 24 weeks (±7 days) post-treatment
Change in Systemic Sclerosis Health Assessment Questionnaire (SHAQ) Score from baseline
Time frame: 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
Time frame: 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
Time frame: Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment
Equipment performance evaluation
Time frame: 0 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous ADRCs injection Combined with Standard Therapy and Standard Treatment group in people with Systemic Sclerosis (SSc) and Hand Dysfunction, run by Cytori Therapeutics at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cochin Hand Function Scale (CHFS) Score from baseline (time frame: Screening period (-30 to -1 day), 24 weeks post-treatment (±7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.