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Stem Cell Therapy

Mesenchymal stem cells for Ileal Pouch (IPAAF 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
Awards & highlights

Summary

This trial is testing whether allogeneic bone marrow derived mesenchymal stem cells are safe and effective at treating people with a peri-pouch fistula related to Crohn's disease of the pouch.

Eligible Conditions
  • Ileal Pouch
  • Crohn's Disease

Timeline

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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mesenchymal stem cellsExperimental Treatment1 Intervention
Direct injection of allogeneic bone marrow derived mesenchymal stem cells at a dose of 75 million cells into the ileal pouch 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 allogeneic bone marrow derived mesenchymal stem cells at a dose of 75 million cells into ileal pouch fistula(s).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesenchymal stem cells
2020
Completed Phase 2
~150

Find a Location

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
Dr Lightener made a mistake during my surgery that has had lifelong consequences. I would not recommend her to anyone.
~8 spots leftby Sep 2025
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