MSC-AFP for Crohn's Disease

Phase-Based Progress Estimates
Mayo Clinic in Rochester, Rochester, MNCrohn's Disease+1 MoreMSC-AFP - Drug
12 - 17
All Sexes
What conditions do you have?

Study Summary

This trial will test if it is safe to use a patient's own cells to coat a plug to treat fistulizing Crohn's disease.

Eligible Conditions
  • Crohn's Disease
  • Anal Fistulas

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 2 months to approximately at 24 months

Month 24
Number of participants with response to the treatment regarding cessation of drainage from the treated fistula.
Number of participants with treatment-related adverse events (safety and toxicity)
Week 24
Number of participants with radiographic response to the treatment regarding the treated fistula.

Trial Safety

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: MSC-AFP · No Placebo Group · Phase 1

Experimental Group · 1 Intervention: MSC-AFP · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 months to approximately at 24 months

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,958 Previous Clinical Trials
3,449,421 Total Patients Enrolled
Michael C StephensPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials

Eligibility Criteria

Age 12 - 17 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have tried standard medical treatments, including anti-TNF drugs, but they have not worked for you.
You have Crohn's disease and have had at least one or more complex fistulas near your anus for three months or longer, even after receiving standard treatment.

Frequently Asked Questions

How many participants have signed up for this clinical trial?

"Affirmative. According to, this trial is still seeking participants and was first made available on July 23rd 2018 . The study's most recent update was September 30th 2022, and 5 individuals are required for the project at a single site." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned MSC-AFP for public use?

"Taking into account the pre-existing data, our team at Power assigned a rating of 1 to MSC-AFP's safety level due it being in the first stage of clinical trials where we can only speculate on its efficacy." - Anonymous Online Contributor

Unverified Answer

Does this trial encompass those aged below 40?

"The trial is offered to patients aged 12 and 17, with 78 trials catering specifically to those under 18 years old and 279 for the senior population." - Anonymous Online Contributor

Unverified Answer

What are the criteria for inclusion in this research initiative?

"Aspiring participants in the clinical trial must have ileocolitis and be between 12 to 17 years old. The study is looking for approximately 5 individuals who meet these criteria." - Anonymous Online Contributor

Unverified Answer

Is this experiment still accepting new participants?

"Correct. According to, this research endeavour was first advertised on July 23 2018 and is currently seeking participants; the study needs 5 volunteers from one location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.