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Stem Cell Therapy

Mesenchymal Stem Cells for Crohn's Disease (PFCD Trial)

Phase 1 & 2

Waitlist Available

Led By Amy Lightner, MD

Research Sponsored by Amy Lightner

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 month 6, month 12

Summary

This trial will test if adult allogeneic bone marrow derived MSCs are safe and effective in treating people with Crohn's disease who have not responded to other treatments.

Eligible Conditions

Crohn's Disease
Perianal Fistulas

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, month 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Treatment related adverse events

Secondary study objectives

Complete clinical healing

Other study objectives

Lack of response

Partial clinical healing

Worsening of disease

Side effects data

From 2021 Phase 1 & 2 trial • 10 Patients • NCT03356821

10%

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Mesenchymal Stem Cells

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mesenchymal Stem CellsExperimental Treatment1 Intervention

Direct injection of adult allogeneic bone marrow derived mesenchymal stem cells, at a dose of 75 million cells into perianal fistula(s) at baseline with a possible repeat injection at 3 months if not completely healed from the first injection.

Group II: PlaceboPlacebo Group1 Intervention

Direct injection of normal saline. If not completely healed after 6 months, participants will then cross over to the treatment group to receive a direct injection of adult allogeneic bone marrow derived mesenchymal stem cells, at a dose of 75 million cells into perianal fistula(s)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mesenchymal Stem Cells

2016

Completed Phase 2

~240

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Who is running the clinical trial?

Amy LightnerLead Sponsor

4 Previous Clinical Trials

110 Total Patients Enrolled

Amy Lightner, MD2.33 ReviewsPrincipal Investigator - The Cleveland Clinic

The Cleveland Clinic

18 Previous Clinical Trials

1,503 Total Patients Enrolled

1Patient Review

I would not recommend this business. I was enrolled in a free clinical trial, but then began receiving bills. They did not inform me that I would no longer qualify for the trial, and showed no remorse for trying to take advantage of me.