← Back to Search

Mesenchymal Stem Cells

2 million hMSC/kg for Rheumatoid Arthritis

Phase 1

Waitlist Available

Led By Nora singer, MD

Research Sponsored by MetroHealth Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Study Summary

This trial is testing whether stem cells can help treat rheumatoid arthritis. It is a phase I clinical trial, which means that its main focus is on safety.

Eligible Conditions

Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety assessed by all adverse events

Safety assessed by change in spirometry

Safety assessed by dose limiting toxicity

+1 more

Secondary outcome measures

Change in patient reported outcomes

DAS28-CRP

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment2 Interventions

6 million hMSC/kg infusion versus placebo infusion

Group II: Cohort 2Experimental Treatment2 Interventions

4 million hMSC/kg infusion versus placebo infusion

Group III: Cohort 1Experimental Treatment2 Interventions

2 million human MSC (hMSC)/kg infusion versus placebo infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

placebo

2010

Completed Phase 4

~6580

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

484 Previous Clinical Trials

1,086,997 Total Patients Enrolled

44 Trials studying Rheumatoid Arthritis

560,997 Patients Enrolled for Rheumatoid Arthritis

MetroHealth Medical CenterLead Sponsor

114 Previous Clinical Trials

21,379 Total Patients Enrolled

Nora singer, MDPrincipal InvestigatorMetroHealth Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial available to individuals younger than 45 years of age?

"As per the stated selection requirements of this clinical trial, participants must be 18 or older but not exceed 80 years in age."

Answered by AI

Are there any opportunities for participants to join this experiment?

"Affirmative. Clinicaltrials.gov lists this medical trial as presently recruiting participants, with the first post being made on December 15th 2017 and a recent update on April 8th 2022. This study requires 20 people to be recruited from one centre."

Answered by AI

Is it possible for me to participate in this research endeavor?

"20 random individuals with a documented diagnosis of rheumatoid arthritis, ranging from 18 to 80 years old are being accepted into this clinical trial. To qualify for the study, applicants must have recently developed RA and maintained stable health in the preceding two weeks. Furthermore, they should possess active joint synovitis in at least one area."

Answered by AI

To what extent is the clinical trial being utilized by participants?

"Yes, the online documentation on clinicaltrials.gov affirms that this experiment is still seeking volunteers. It was inaugurated in December 15th 2017 and latest edited on April 8th 2022. 20 people are required to participate at a single clinic site."

Answered by AI

How deleterious is a dose of 2 million hMSC/kg for patients?

"Due to the limited safety data that accompanies a Phase 1 trial, our team has rated the 2 million hMSC/kg intervention as moderately safe with a score of 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mesenchymal Stem Cells in Early Rheumatoid Arthritis

Nora G. Singer 2017. "Mesenchymal Stem Cells in Early Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03186417.