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Mesenchymal Stem Cells
Stem Cell Therapy for Fistulas in Crohn's Disease
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 who have undergone an ileal pouch anal anastomosis at least 6 months prior and have developed a clinical diagnosis of Crohn's disease of the pouch
Failed oral antibiotic therapy
Must not have
Clinically significant medical conditions within the six months before administration of vBM-MSCs
Daily use of prednisone of greater than 20 mg per day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
Summary
This trial is testing whether a treatment made from a person's own stem cells can help heal a Crohn's-related fistula.
Who is the study for?
This trial is for adults aged 18-75 with Crohn's disease who have had an ileal pouch anal anastomosis and developed a fistula. They must have tried and not responded to conventional therapies, including immune suppression or biologics, for at least 3 months. Participants should be stable on current Crohn's medications for over 3 months and able to give informed consent.
What is being tested?
The study tests the safety of Ossium vBM-MSCs in treating fistulas among those with Crohn's disease-related pouch complications. Patients will either receive these stem cells or a placebo to see if there’s a difference in effectiveness between the two groups.
What are the potential side effects?
While specific side effects are not listed, Mesenchymal Stem Cell treatments can potentially cause immune reactions, infection risks, pain at injection site, fever, headache or nausea. The exact side effects will be monitored closely during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18-75 years old and have Crohn's disease in my pouch, diagnosed after surgery.
Select...
Oral antibiotics did not work for my condition.
Select...
I have a fistula from my ileal pouch or anal canal to my skin or vagina.
Select...
Standard treatments have not worked for me.
Select...
I am capable of understanding and signing the consent form.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had any major health issues in the last 6 months.
Select...
I take more than 20 mg of prednisone daily.
Select...
I am HIV positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete clinical healing
Lack of response
Partial healing
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vertebral Bone Marrow Derived Mesenchymal Stem Cells (vBM-MSC)Experimental Treatment1 Intervention
Direct injection of vertebral bone marrow derived mesenchymal stem cells at a dose of 100 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 vertebral allogeneic bone marrow derived mesenchymal stem cells at a dose of 100 million cells into ileal pouch fistula(s).
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Who is running the clinical trial?
Amy LightnerLead Sponsor
4 Previous Clinical Trials
130 Total Patients Enrolled
4 Trials studying Fistula
130 Patients Enrolled for Fistula
Ossium Health, Inc.Industry Sponsor
9 Previous Clinical Trials
128 Total Patients Enrolled
1 Trials studying Fistula
Amy Lightner, MDPrincipal InvestigatorThe Cleveland Clinic
18 Previous Clinical Trials
1,523 Total Patients Enrolled
7 Trials studying Fistula
166 Patients Enrolled for Fistula
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18-75 years old and have Crohn's disease in my pouch, diagnosed after surgery.I am on stable doses of medication for Crohn's disease for over 3 months.My Crohn's disease treatment hasn't changed in the past 2 months and won't change in the next 2 months.Oral antibiotics did not work for my condition.I have a fistula from my ileal pouch or anal canal to my skin or vagina.I haven't had any major health issues in the last 6 months.I haven't taken any experimental drugs in the last 30 days.Standard treatments have not worked for me.I take more than 20 mg of prednisone daily.I am capable of understanding and signing the consent form.I have had cancer, including melanoma, within the last year.I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: Vertebral Bone Marrow Derived Mesenchymal Stem Cells (vBM-MSC)
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
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