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Tests treatment safety and results for Systemic Sclerosis (SSc)
Official title Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis
ClinicalTrials.gov ID: NCT07360808
What this study is testing
What is Standard Treatment group?
Standard Treatment group is an investigational medicine, being studied as a potential treatment for systemic sclerosis (ssc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- 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...
You likely can't join 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...
- Active infectious diseases or patients who have used antibiotics within 3 months before the screening visit due to active infectious diseases;
See the full eligibility criteria
- 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...
- Voluntary participation in this clinical trial and signing the informed consent form by the subject.
- 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 how well it works evaluation of the hand and do not affect the...
- 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...
- 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...
- 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...
- Any of the following laboratory test results during the screening period: ① Abnormal blood routine: hemoglobin \ 1.5 times the upper limit of the reference value; ③ Coagulation dysfunction: prothrombin time (PT) and...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.