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Stem Cell Therapy

Mesenchymal stem cells for 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

Study Summary

This trial will test if injecting stem cells into fistulas can heal them. 10 patients aged 13-17 will be treated at baseline and again 3 months later if needed.

Eligible Conditions

Crohn's Disease Perianal Fistula

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 clinical healing

+1 more

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

Do I qualify?Apply below to find out

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

1,614 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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the upper age limit for entry into this experiment above sixty years?

"This trial stipulates that only those between 13 and 17 years of age can participate. There are 321 trials for minors, while 899 studies cater to individuals aged over 65."

Answered by AI

What is the aggregate count of participants engaged in this clinical trial?

"Absolutely. The information posted on clinicaltrials.gov affirms that recruitment is ongoing for this medical trial, initially listed on April 1st 2021 and most recently updated a year later. 10 patients are needed from one particular site."

Answered by AI

Who qualifies to participate in this experiment?

"This study seeks out 10 patients with a particular disease between the ages of 13 and 17. Applicants must have single or multiple-tract perianal fistula, be able to employ contraception or abstinence during the trial, not suffer from claustrophobia nor have any contraindications for MRI evaluations (e.g., pacemaker)."

Answered by AI

Is there still time to enroll in this experiment?

"Affirmative. Clinicaltrials.gov hosts the information that this medical trial is actively seeking patients, with 10 participants required from a single site since it was initially posted on April 1st 2021 and most recently updated again on April 1st 2022."

Answered by AI