Status:
AVAILABLE
Infusion of Allogeneic Mesenchymal Stem Cells in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement
Lead Sponsor:
Universidad de la Sabana
Collaborating Sponsors:
Fundación Neumologica Colombiana
Innocell SAS
Conditions:
Systemic Sclerosis Pulmonary
Pulmonary Hypertension
Eligibility:
All Genders
18-65 years
Brief Summary
Progressive SSc is an entity with limited therapeutic alternatives and with asurvival rate of less than 45% in the first 3 to 5 years. The disease causessevere limitation in quality of life ranging fr...
Detailed Description
This study aims to evaluate the therapeutic effects of allogeneic mesenchymal stromal cell infusion as a treatment in patients with systemic sclerosis refractoryto conventional therapy. The group of p...
Eligibility Criteria
Inclusion
- Age\> 18 years and \<65 years.• Established diagnosis of systemic sclerosis according to the criteria of theAmerican College of Rheumatology• SSc of poor prognosis, involving life-threatening severe visceralinvolvement (cardiac or pulmonary hypertension ), lack of response toconventional immunosuppressive therapy used in severe forms of thedisease according to the European recommendations of EUSTAR and EBMT, relying on high doses of IV cyclophosphamide (either in monthlybolus for at least six months); or SSc with life-threatening pulmonaryhypertension. Patients may or may not have pulmonary fibrosis.• Signed informed consent.• Presence of a consenting MSC donor• Affiliation to social security
Exclusion
- Pregnancy or absence of appropriate contraception throughout the study.• Pulmonary artery systolic pressure (PASP) \>75mmHg (onechocardiography or after right heart catheterization);- Theorical DLCO \<30%• Calculated creatinine clearance \<30 ml/mn/m2• Clinical sign of a congestive heart failure refractory ;• Left ventricular ejection fraction \<35% at myocardial scintigraphy orechocardiography;• Chronic atrial fibrillation requiring oral anticoagulant therapy;• Uncontrolled ventricular arrhythmia;• Pericardial effusion with hemodynamic compromise assessed byechocardiography.• Hepatic impairment defined as a persistent increase in transaminases orbilirubin to 3 times normal.• Psychiatric disorders, including drug taking and alcohol abuse.• Active neoplasia or concomitant myelodysplasia, antecedent of neoplasia.• Bone marrow failure defined by neutropenia \<0.5 x 109 / L,thrombocytopenia \<50 x 109 / L, anemia \<8 g / dL, CD4 lymphopenia \<200x 106 / L.• Uncontrolled systemic hypertension.• Uncontrolled acute or chronic infection, HIV1, 2 or HTLV-1, 2seropositivity.• Chronic hepatitis B or C active.• Significant exposure to bleomycin, toxic oils, vinyl chloride,trichloroethylene or silica; eosinophilia-myalgia syndrome, eosinophiliafasciitis.• Risk of poor patient compliance
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04432545
Last Update
April 8 2024
Active Locations (1)
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1
Universidad de la Sabana
Chía, Chia, Colombia