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New treatment option for Sclerosis, Systemic
Official title Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis
ClinicalTrials.gov ID: NCT04356287
What this study is testing
What is UCMSC?
UCMSC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sclerosis, systemic.
Also referred to as umbilical cord derived mesenchymal stromal cells.
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
- The purpose of this study is to test the safety and efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UCMSC) for the treatment of Systemic Sclerosis (SSc).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- SSc according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2103 classification criteria for systemic sclerosis
- Severe disease defined as: i) disease duration of 2 years or less with an mRss of \> 20 and (ESR \> 25 mm and/or hemoglobin \ 15 without any...
- Inadequate response (determined by patient and physician judgement) or adverse events necessitating discontinuation of standard therapy (usually...
- Ineligibility or unwillingness to undergo autologous hematopoietic stem cell transplant
You likely can't join if
- Age \< 18 years
- Pregnancy or unwillingness to use adequate contraception
- Life-threatening end-organ damage defined as:
- FVC \< 45% and/or 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...
See the full eligibility criteria
- SSc according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2103 classification criteria for systemic sclerosis
- Severe disease defined as: i) disease duration of 2 years or less with an mRss of \> 20 and (ESR \> 25 mm and/or hemoglobin \ 15 without any restriction as to disease duration plus at least one major organ involvement...
- Inadequate response (determined by patient and physician judgement) or adverse events necessitating discontinuation of standard therapy (usually consisting of methotrexate 25 mg subcutaneous (or as tolerated) per week...
- Ineligibility or unwillingness to undergo autologous hematopoietic stem cell transplant
- Age \< 18 years
- Pregnancy or unwillingness to use adequate contraception
- Life-threatening end-organ damage defined as:
- FVC \< 45% and/or 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 \> 25 mmHg (and pulmonary wedge pressure \< 15 mmHg) on right...
- stage 4 or more chronic kidney disease (glomerular filtration rate \< 30 ml/min)
- Liver failure defined as an abnormal transaminase level (aspartate aminotransferase (ASAT), alanine aminotransaminase (ALAT) \> 3 normal) unless related to activity of the disease
- Concurrent neoplasms or myelodysplasia
- Uncontrolled hypertension
- Uncontrolled acute or chronic infection (HIV, HTLV-1/2 (Human T-lymphotropic virus), hepatitis B surface Ag positive, hepatitis C positive) or high risk thereof
- Significant malnutrition with BMI \< 18 kg/m2
- Severe concomitant psychiatric disorder
- Bone marrow insufficiency defined as neutropenia \< 0.5 x 109 cell/L, thrombocytopenia \< 30 x 109 cell/L, anemia \< 8g/dL, CD4+ T lymphopenia \< 200 x 106 cell/L due to other diseases than SSc (CD4 - cluster of...
- History of poor compliance
- Concurrent enrolment in any other protocol using an investigational drug
- Inability to provide informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. 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.