An interventional study of Autologous ADRCs injection Combined with Standard Therapy and Standard Treatment group in Systemic Sclerosis (SSc) and Hand Dysfunction, sponsored by Cytori Therapeutics. Recruiting at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Cytori Therapeutics · Not applicable, Interventional, and Treatment
Among 81 studies in Scleroderma, Systemic with a site in China — 63 open to participants now, 68 under way, 4 of them phase 3. Scleroderma, Systemic · China.
Among the 81 studies in Scleroderma, Systemic with a site in China, this one is the 18th largest by planned enrollment of the 76 interventional ones that give a count, is one of 29 that started in 2025, is one of 14 with no phase, reaches primary completion later than 43 of the 67 other live ones, and was the 61st registered.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
Browse Scleroderma, Systemic studies →63 of the 81 studies in Scleroderma, Systemic with a site in China are open now. Recruiting first, the newest first:
Antengene Biologics Limited · Sites in China
AstraZeneca · Sites in China, United States, Argentina and 32 more countries
Boehringer Ingelheim · Sites in China, United States, Argentina and 42 more countries
The First Affiliated Hospital with Nanjing Medical University · Sites in China
The Children's Hospital of Zhejiang University School of Medicine · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 144 Scleroderma, Systemic studies recruiting now, 82 (57%) set no upper age limit and 49 (34%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
81 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 47 · Phase 2 13 · Phase 3 7 · Phase 4 4
First in 2008; this study’s year is marked. 29 started in 2025.
This study's planned enrollment of 48 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Median enrollment 20 across the 76 interventional studies, 490 across the 5 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
33 of 81 have an industry lead sponsor. The 10 most frequent:
Cytori Therapeutics is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Cytori Therapeutics has 2 studies filed under Scleroderma, Systemic — fewer than ten, so there is no comparison to draw.
18 of the studies in Scleroderma, Systemic with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT07236801China Immunotech (Beijing) Biotechnology Co., Ltd.Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases | 2026-11-13 |
| NCT06822881Beijing GoBroad HospitalCT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc) | 2026-12-31 |
| NCT06548607Nanjing Bioheng Biotech Co., Ltd.Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases | 2026-12-31 |
| NCT07641634Prolium Bioscience, IncA Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis. | 2027-01 |
Among the 81 studies in Scleroderma, Systemic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Autologous ADRCs injection Combined with Standard Therapy
Drug: Standard Treatment group
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.
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.
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)
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
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: 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.
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
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.
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
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.
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
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.
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
The evaluation was conducted by the researchers. The thickness of the skin on the hands was measured using ultrasound.
Time frame: 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).
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
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.
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
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.
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
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".
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
Incidence of breakage of connecting components, loosening and falling off of components, and electric leakage of the control system in the Celution800/GP system (%)
Time frame: 0 day
Vital signs: body temperature
Time frame: Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment
Vital signs: respiration
Time frame: Screening period (-30 to -1 day), 4 weeks (±3 days), 12 weeks (±7 days) and 24 weeks (±7 days) post-treatment
Vital signs: pulse
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 (＋/-)
Time frame: 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 (＋/-)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 0 day
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2027, 24 months after the start.
Of 100 interventional studies with no phase under Scleroderma, Systemic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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