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Stem Cell Therapy

Mesenchymal Stem Cells for Crohn's Disease (RVF 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 is testing a new treatment using special cells from donor bone marrow to heal rectovaginal fistulas in women with Crohn's disease. These cells are injected directly into the affected area to help repair the tissue. The study aims to see if this method is safe and effective, especially for those who haven't had success with other treatments.

Eligible Conditions

Crohn's Disease
Rectovaginal Fistula
Vulvar Crohn's disease
Anal fistula

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

Lack of response

Partial healing

+1 more

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 rectovaginal fistula 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 with a possible repeat injection at 3 months if not completely healed from the first injection. 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 rectovaginal fistula.

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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