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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

Must not have

Significant malnutrition with BMI < 18 kg/m2

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 differentiation 4)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not eligible for or do not want a stem cell transplant using my own cells.

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I have been diagnosed with systemic sclerosis according to ACR/EULAR 2013 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is under 18, indicating significant malnutrition.

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I have low blood counts not caused by systemic sclerosis.

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I do not have any uncontrolled infections like HIV or hepatitis.

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My high blood pressure is not under control.

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You have severe damage to your lungs, heart, kidneys, or liver.

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I do not have any other cancers or bone marrow disorders.

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I am under 18 years old.

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I am not pregnant and willing to use contraception.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure of safety one month after first infusion

Secondary study objectives

Change in modified Rodnan skin score (mRss) between Month 0 and Month 12

Other study objectives

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 more

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.

0 / 10Eligibility criteria met