Your session is about to expire
← Back to Search
Stem Cell Therapy
Mesenchymal Stem Cells for Perianal Fistulas (PFCD Trial)
Phase 1 & 2
Recruiting
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
Men and Women 18-75 years of age with a diagnosis of Crohn's disease for at least six months duration.
Single and Multi-tract Perianal fistula, with or without previous failed surgical repair.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6, month 12
Awards & highlights
PFCD Trial 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
- Perianal Fistulas
- Crohn's Disease
PFCD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPFCD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6, month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment related adverse events
Secondary outcome measures
Complete clinical healing
Other outcome measures
Lack of response
Partial clinical healing
Worsening of disease
Side effects data
From 2020 Phase 1 trial • 14 Patients • NCT0286672133%
Vomiting
33%
Non-cardiac Chest Pain
33%
Abdominal Pain
33%
Generalized Pain
33%
Change in Appetite
33%
Risk of Pathogen Exposure
33%
Hypomagnesemia
33%
Myalgia
33%
Lethargy
33%
Syncope
33%
Increased Sputum Production
33%
Cough
33%
PICC Line Insertion
33%
Diarrhea
33%
Cystic Fibrosis Pulmonary Exacerbation
33%
Constipation
33%
PICC Line Right Upper Extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
1 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram
3 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram
5 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram
PFCD 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
~200
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
1,584 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Share this study with friends
Copy Link
Messenger