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UCMSC for Systemic Sclerosis (CARE-SSc Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Marie Hudson, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ineligibility or unwillingness to undergo autologous hematopoietic stem cell transplant
SSc according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2103 classification criteria for systemic sclerosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
CARE-SSc Trial Summary
This trialwill test if UCMSC are a safe & effective way to treat Systemic Sclerosis (SSc).
Who is the study for?
Adults with Systemic Sclerosis who haven't responded well to or can't tolerate standard treatments like methotrexate and mycophenolate mofetil. They should have severe disease symptoms, but not life-threatening organ damage or other serious health issues like uncontrolled infections, malnutrition, or heart failure.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Umbilical Cord-derived Mesenchymal Stromal Cells (UCMSC) compared to a placebo in treating Systemic Sclerosis. Participants will be randomly assigned to receive either UCMSC or a placebo.See study design
What are the potential side effects?
While specific side effects for UCMSC are not detailed here, similar treatments may cause immune reactions, infection risks, infusion-related responses, and potential impacts on blood counts.
CARE-SSc Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not eligible for or do not want a stem cell transplant using my own cells.
Select...
I have been diagnosed with systemic sclerosis according to ACR/EULAR 2013 criteria.
CARE-SSc Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure of safety one month after first infusion
Secondary outcome measures
Change in modified Rodnan skin score (mRss) between Month 0 and Month 12
Other outcome measures
36-Item Short Form Survey version 2 for health-related quality of life (SF-36v2)
ACR Provisional Composite Response Index
EuroQoL health status measure (EQ-5D-5L)
+8 moreCARE-SSc Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Two infusions of UCMSCExperimental Treatment1 Intervention
Patients receive one intravenous infusion of UCMSC at month 0 and one intravenous infusion of UCMSC at month 3. Each experimental infusion will consist of 1 million UCMSC/kg suspended in 50 ml of PlasmaLyte A.
Group II: One infusion of UCMSCExperimental Treatment1 Intervention
Patients receive one intravenous infusion of UCMSC at month 0 and one intravenous infusion of placebo at month 3. Each experimental infusion will consist of 1 million UCMSC/kg suspended in 50 ml of PlasmaLyte A. Each placebo infusion will consist of a similar volume of PlasmaLyte A.
Group III: Placebo infusionsPlacebo Group1 Intervention
Patients receive intravenous placebo infusions at months 0 and 3. Each placebo infusion will consist of 50 ml of PlasmaLyte A.
Find a Location
Who is running the clinical trial?
University Paris 7 - Denis DiderotOTHER
21 Previous Clinical Trials
88,557 Total Patients Enrolled
Université de MontréalOTHER
214 Previous Clinical Trials
102,753 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
446 Previous Clinical Trials
159,708 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is under 18, indicating significant malnutrition.You have a history of not following instructions or not taking medication as directed.You have severe damage to your lungs, heart, kidneys, or liver.I have low blood counts not caused by systemic sclerosis.I have severe SSc with major organ involvement or high disease activity.I am not eligible for or do not want a stem cell transplant using my own cells.I do not have any uncontrolled infections like HIV or hepatitis.My high blood pressure is not under control.I have been diagnosed with systemic sclerosis according to ACR/EULAR 2013 criteria.I do not have any other cancers or bone marrow disorders.My current medication for my condition isn't working or causes severe side effects.I am under 18 years old.I am not pregnant and willing to use contraception.You have a serious mental health condition at the same time as the study.
Research Study Groups:
This trial has the following groups:- Group 1: One infusion of UCMSC
- Group 2: Two infusions of UCMSC
- Group 3: Placebo infusions
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently recruiting participants?
"Affirmative. According to clinicaltrials.gov, this experiment is still recruiting participants and was initially publicised on January 5th 2023 with a recent update occurring on the same day. A total of 18 patients are required across one medical research site."
Answered by AI
How many participants have been accepted into the trial thus far?
"Affirmative. According to clinicaltrials.gov, this medical research has been recruiting patients since its first posting on the 5th of January 202023 and is actively searching for 18 volunteers from a single clinic site."
Answered by AI
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