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Mesenchymal Stromal Cell Therapy
Stem Cell-Coated Plug for Crohn's Fistula
Phase 1
Waitlist Available
Led By Michael C Stephens
Research Sponsored by Mayo Clinic
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 2 months to approximately at 24 months
Awards & highlights
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.
Who is the study for?
This trial is for U.S. residents aged 12-17 with Crohn's disease who have had complex perianal fistulas for at least three months despite standard treatments, including anti-TNF agents. They must be able to undergo MR evaluations and not have any serious recent medical conditions or infections, no history of cancer (except certain skin cancers), and not be pregnant.Check my eligibility
What is being tested?
The study tests the safety of a new treatment where a plug coated with the patient's own mesenchymal stromal cells (MSCs) is used to treat fistulizing Crohn's disease. The MSC-AFP aims to promote healing in patients who haven't responded well to other therapies.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with cell therapies such as immune reactions, infection at the implant site, or complications from MR evaluations required by the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months to approximately at 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months to approximately at 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events (safety and toxicity)
Secondary outcome measures
Number of participants with radiographic response to the treatment regarding the treated fistula.
Number of participants with response to the treatment regarding cessation of drainage from the treated fistula.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MSC-AFPExperimental Treatment1 Intervention
This is a single treatment group study. All patients will receive treatment of a stem cell coated fistula plug.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MSC-AFP
2016
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,082 Total Patients Enrolled
Michael C StephensPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have Crohn's disease with multiple deep sores near the anus that have not healed for at least three months, even with standard treatment.You have a history of significant autoimmune diseases, except Crohn's disease, or any previous autoimmune disease affecting your fat tissues.You have had cancer in the past, except for non-spreading skin cancers.You have taken any experimental medication in the past month.You had an allergic reaction to a previous treatment for a perianal fistula.If it is not possible to collect or study fat tissue.You are allergic to the numbing medicine used for local anesthesia.You have abnormal connections between your rectum and vagina or between your intestines and bladder.
Research Study Groups:
This trial has the following groups:- Group 1: MSC-AFP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have signed up for this clinical trial?
"Affirmative. According to clinicaltrials.gov, 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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Is this experiment still accepting new participants?
"Correct. According to clinicaltrials.gov, this research endeavour was first advertised on July 23 2018 and is currently seeking participants; the study needs 5 volunteers from one location."
Answered by AI
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