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Phase I/II randomized clinical trial of allogeneic adipose tissue-derived mesenchymal stromal cells systemic infusion in severe systemic sclerosis MSC-AT-SSc
EU CTIS ID: 2023-505977-34-00
What this study is testing
To evaluate the safety one month after allogeneic 2x106 MSC(AT)/kg intravenous administration once or twice at 3 months interval (M0, M3) in severe SSc patients
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Provide signed and dated informed consent
- 10) Health insurance
- 2) Willing to comply with all study procedures and be available for the duration of the study;
- 3) Male or female, aged ≥ 18 years and ≤ 80 years of age
- 4) SSc patients according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2013 classification criteria for SSc
- 5) Severe disease with either: a) disease duration of 2 years or less with a modified Rodnan skin score (mRSS) ≥ 20 and (abnormal CRP > 5 mg/l and/or hemoglobin < 11 g/dL), or b) mRSS ≥ 15 without any restriction as to disease duration plus at least one major organ involvement as defined by: (1) respiratory involvement consisting of lung diffusion capacity for carbon monoxide (DLCO) and/or forced vital capacity (FVC) < 80% predicted and evidence of interstitial lung disease (chest X-ray and/or high resolution computed tomography (HRCT) scan) and/or moderate Pulmonary hypertension with baseline resting systolic pulmonary arterial pressures > 35 mmHg and below 50 mmHg by cardiac echocardiography, or mean pulmonary artery pressure > 20 mmHg and < 40 mm Hg on right heart catheterization; (2) renal involvement consisting of past renal crisis, microangiopathic hemolytic anemia, and/or renal insufficiency not explained by other causes than SSc; (3) cardiac involvement consisting of reversible congestive heart failure, atrial or ventricular rhythm disturbances such as recurrent episodes of atrial fibrillation or flutter, recurrent atrial paroxysmal tachycardia, 2nd or 3rd degree AV-block, mild to moderate pericardial effusion and/or presence of MRI involvement (Increased T1 or T2 mapping, late gadolinium enhancement, septal D sign) . All causes of organ involvement should be attributed to SSc.
You likely can't join if
- 1. Age < 18 years or > 80 years
- 10. Severe psychiatric disorder
- 11. Bone marrow insufficiency, defined as neutropenia < 1 x 109/L, thrombopenia < 50 x 109/L, anemia < 8 g/dL, lymphopenia < 0,5 x 109/L
- 12. Inability to provide informed consent
- 13. Patient included in another interventional clinical trial
- 14. Patient under tutelle
See the full eligibility criteria
Who can join
- 1) Provide signed and dated informed consent
- 10) Health insurance
- 2) Willing to comply with all study procedures and be available for the duration of the study;
- 3) Male or female, aged ≥ 18 years and ≤ 80 years of age
- 4) SSc patients according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2013 classification criteria for SSc
- 5) Severe disease with either: a) disease duration of 2 years or less with a modified Rodnan skin score (mRSS) ≥ 20 and (abnormal CRP > 5 mg/l and/or hemoglobin < 11 g/dL), or b) mRSS ≥ 15 without any restriction as to disease duration plus at least one major organ involvement as defined by: (1) respiratory involvement consisting of lung diffusion capacity for carbon monoxide (DLCO) and/or forced vital capacity (FVC) < 80% predicted and evidence of interstitial lung disease (chest X-ray and/or high resolution computed tomography (HRCT) scan) and/or moderate Pulmonary hypertension with baseline resting systolic pulmonary arterial pressures > 35 mmHg and below 50 mmHg by cardiac echocardiography, or mean pulmonary artery pressure > 20 mmHg and < 40 mm Hg on right heart catheterization; (2) renal involvement consisting of past renal crisis, microangiopathic hemolytic anemia, and/or renal insufficiency not explained by other causes than SSc; (3) cardiac involvement consisting of reversible congestive heart failure, atrial or ventricular rhythm disturbances such as recurrent episodes of atrial fibrillation or flutter, recurrent atrial paroxysmal tachycardia, 2nd or 3rd degree AV-block, mild to moderate pericardial effusion and/or presence of MRI involvement (Increased T1 or T2 mapping, late gadolinium enhancement, septal D sign) . All causes of organ involvement should be attributed to SSc.
- 6) Contraindication, inadequate response or unwillingness to undergo AHSCT (determined by patient and physician judgement)
- 7) Contraindication, inadequate response or unwillingness or adverse events necessitating discontinuation of conventional immunosuppressive therapy, except for MMF and methotrexate);
- 8) Women of reproductive potential must use highly effective contraception;
- Men of reproductive potential must use condoms
What rules you out
- 1. Age < 18 years or > 80 years
- 10. Severe psychiatric disorder
- 11. Bone marrow insufficiency, defined as neutropenia < 1 x 109/L, thrombopenia < 50 x 109/L, anemia < 8 g/dL, lymphopenia < 0,5 x 109/L
- 12. Inability to provide informed consent
- 13. Patient included in another interventional clinical trial
- 14. Patient under tutelle
- 2. Pregnancy or unwillingness to use adequate contraception;
- 3. Life-threatening end-organ damage defined as: DLCO (corrected for hemoglobin) < 30% predicted; Left ventricular ejection fraction < 40% by cardiac echocardiography; Pulmonary hypertension with baseline resting systolic pulmonary arterial pressures > 50 mmHg by cardiac echocardiography, or mean pulmonary artery pressure > 40 mmHg on right heart catheterization; glomerular filtration rate < 30mL/min
- 4. Active or chronic Hepatitis (ASAT, ALAT > 3 upper limit normal)
- 5. Neoplasms of less than 5 years, except for basal cell or in situ cervix carcinoma or concurrent myelodysplasia,
- 6. Uncontrolled hypertension
- 7. Uncontrolled acute or chronic infection
- 8. HIV-1 or HIV-2 infection
- 9. BMI < 16.5 kg/m2
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.