← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

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.

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

Complete clinical healing

Lack of response

Partial healing

+2 more

Trial 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).

0 / 5Eligibility criteria met

Find a Location

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

1,604 Total Patients Enrolled

7 Trials studying Fistula

166 Patients Enrolled for Fistula

Media Library

Ossium vBM-MSC (Mesenchymal Stem Cells) Clinical Trial Eligibility Overview. Trial Name: NCT05075811 — Phase 1 & 2

Fistula Research Study Groups: Vertebral Bone Marrow Derived Mesenchymal Stem Cells (vBM-MSC), Placebo

Fistula Clinical Trial 2023: Ossium vBM-MSC Highlights & Side Effects. Trial Name: NCT05075811 — Phase 1 & 2

Ossium vBM-MSC (Mesenchymal Stem Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05075811 — Phase 1 & 2

Frequently Asked Questions

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

What is the maximum enrollment capacity for this research study?

"Affirmative. Clinicaltrials.gov exhibits that this medical trial, first established on February 1st 2022, is actively seeking participants. As of now, 20 individuals are expected to be enlisted from a single site."

Answered by AI

Do you have any openings for this trial currently?

"Affirmative. According to clinicaltrials.gov, this medical research is actively searching for participants and was initially posted on February 1st 2022. The trial requires 20 volunteers from a single centre for its duration."

Answered by AI

Is eligibility for this research limited to individuals age 45 or younger?

"This trial is open to individuals aged between 18 and 75. Those who are younger than 18 or older than 65 may find alternative studies, as there are 78 trials for those in the former's demographic and 280 for those in the latter's."

Answered by AI

Are there opportunities to join this research endeavor?

"To be considered for this clinical trial, candidates must possess a fistula and fit within the age range of 18-75 years old. This medical study is currently looking to enroll up to 20 participants."

Answered by AI

Recent research and studies

British Journal of SurgeryJournal

J Ileal Pouch–anal Anastomosis for Chronic Ulcerative Colitis: Complications and Long-term Outcome in 1310 Patients

Meagher, A P, R Farouk, R R Dozois, K A Kelly, and J H Pemberton. 1998. “J Ileal Pouch–anal Anastomosis for Chronic Ulcerative Colitis: Complications and Long-term Outcome in 1310 Patients”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1046/j.1365-2168.1998.00689.x.

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.

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