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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

IPAAF Trial 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

IPAAF Trial 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

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
Lack of response
Partial healing
+1 more

IPAAF 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
1,584 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.

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
Annals of SurgeryJournal
Ileal Pouch Anal Anastomosis
Fazio, Victor Warren, Ravi P. Kiran, Feza H. Remzi, John Calvin Coffey, Helen Mary Heneghan, Hasan Tarik Kirat, Elena Manilich, Bo Shen, and Sean T. Martin. 2013. “Ileal Pouch Anal Anastomosis”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0b013e31827d99a2.
Diseases of the Colon & RectumJournal
Repeat Pouch Surgery by the Abdominal Approach Safely Salvages Failed Ileal Pelvic Pouch
Remzi, Feza H., Victor W. Fazio, Hasan T. Kirat, James S. Wu, Ian C. Lavery, and Ravi P. Kiran. 2009. “Repeat Pouch Surgery by the Abdominal Approach Safely Salvages Failed Ileal Pelvic Pouch”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/dcr.0b013e31819ad4b6.
GastroenterologyJournal
Allogeneic Bone Marrow–derived Mesenchymal Stromal Cells Promote Healing of Refractory Perianal Fistulas in Patients with Crohn’s Disease
Molendijk, Ilse, Bert A. Bonsing, Helene Roelofs, Koen C.M.J. Peeters, Martin N.J.M. Wasser, Gerard Dijkstra, C. Janneke van der Woude, et al.. 2015. “Allogeneic Bone Marrow–derived Mesenchymal Stromal Cells Promote Healing of Refractory Perianal Fistulas in Patients with Crohn’s Disease”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2015.06.014.
GastroenterologyJournal
Long-term Efficacy and Safety of Stem Cell Therapy (cx601) for Complex Perianal Fistulas in Patients with Crohn’s Disease
Panés, Julián, Damián García-Olmo, Gert Van Assche, Jean Frederic Colombel, Walter Reinisch, Daniel C. Baumgart, Axel Dignass, et al.. 2018. “Long-term Efficacy and Safety of Stem Cell Therapy (cx601) for Complex Perianal Fistulas in Patients with Crohn’s Disease”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2017.12.020.
All > Crohns Disease
~9 spots leftby Apr 2025
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