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Stem Cell Therapy
Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease
Phase 1
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 younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
No Placebo-Only Group
Summary
This trial involves injecting special cells from donated bone marrow into teenagers with severe Crohn's disease that hasn't improved with other treatments. These cells help repair and heal the damaged tissue. Bone marrow transplants have been used to treat various diseases, including leukemia, aplastic anemia, and autoimmune diseases.
Eligible Conditions
- Perianal fistula
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
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 clinical healing
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mesenchymal stem cellsExperimental Treatment1 Intervention
allogeneic bone marrow derived mesenchymal stem cells
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
140 Total Patients Enrolled
Amy Lightner, MD2.33 ReviewsPrincipal Investigator - The Cleveland Clinic
The Cleveland Clinic
18 Previous Clinical Trials
1,473 Total Patients Enrolled
1Patient Review
I had a very negative experience with Dr. Lightener. She caused me a great deal of harm and pain. I would not recommend her to anyone.