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Stem Cell Therapy

Cell Therapy for Intestinal Transplant Recipients

Phase 1
Recruiting
Led By Tomoaki Kato, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Malabsorption: Microvillus Inclusion Disease, Tufting Enteropathy, Complete portomesenteric thrombosis with cirrhosis
Short Bowel Syndrome (SBS) due to: Trauma (multiple resections/explorations and/or vascular abdominal trauma superior mesenteric artery (SMA) / superior mesenteric vein (SMV) injuries), Gastroschisis, Volvulus, Necrotizing Enterocolitis, Intestinal Atresia, Crohn's Disease, Hirschprung's Disease, Chronic Intestinal Pseudo-Obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years after transplantation
Awards & highlights

Study Summary

This trial is investigating whether it is safe to give stem cells from a donor's bone marrow to patients who have had an intestinal transplant, in order to try and reduce the amount of immunosuppression medication needed.

Who is the study for?
This trial is for adults aged 18-65 who need an intestinal transplant and can follow up for 48 months. It's open to those listed in UNOS, with conditions like Short Bowel Syndrome or specific tumors, but not for those with multi-organ failure, severe infections, or unstable health conditions. Pregnant women and individuals unable to use birth control are excluded.Check my eligibility
What is being tested?
The study tests the safety of using donor bone marrow cells (CD34+ stem cells) after an intestinal transplant to reduce rejection and lower immunosuppressant needs. The aim is achieving 'mixed chimerism,' where both recipient's and donor's cells coexist harmoniously.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to mixed chimerism, increased risk of infection from reduced immunosuppression levels, possible graft-versus-host disease symptoms, or complications related to bone marrow cell infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a severe intestinal disorder affecting nutrient absorption.
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I have Short Bowel Syndrome from surgery, injury, or a specific condition.
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I am between 18 and 65 years old.
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I can sign the consent form by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years after transplantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years after transplantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total number of participants with moderate to severe GVHD
Secondary outcome measures
Graft survival rate
Retention rate

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cell TherapyExperimental Treatment1 Intervention
Patients will receive an infusion containing 1x106/kg CD34+ cells. No more than 104 CD34+ T cells per kg recipient weight will be included in the infusion. Cadaveric donor CD34 cell infusion will occur at any time between post-operative day 11 to day 13 following transplantation.
Group II: ControlActive Control1 Intervention
Patients who do not consent to receive donor CD34 cell infusion or whose donor family declines consent for research use of donor bone marrow will receive their usual standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cell Therapy
2016
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,827 Total Patients Enrolled
Ossium Health, Inc.Industry Sponsor
9 Previous Clinical Trials
142 Total Patients Enrolled
Tomoaki Kato, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

CD34+ stem cells (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04804891 — Phase 1
Intestinal Transplant Research Study Groups: Cell Therapy, Control
Intestinal Transplant Clinical Trial 2023: CD34+ stem cells Highlights & Side Effects. Trial Name: NCT04804891 — Phase 1
CD34+ stem cells (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04804891 — Phase 1

Frequently Asked Questions

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

Is recruitment for this trial ongoing?

"Correct. According to the information on clinicaltrials.gov, this medical trial is still looking for participants, which was posted on October 22nd 2021 and updated most recently at the end of December 2021. Currently there needs to be 6 patients recruited from a single centre."

Answered by AI

What is the current enrollment number for this trial?

"Affirmative. Clinicaltrials.gov's data suggests that this clinical trial is currently recruiting individuals for enrollment - the research was first posted on October 22nd 2021 and its most recent update occurred December 28th of the same year. Specifically, 6 patients are sought from a single medical centre."

Answered by AI

What are the eligibility criteria for participating in this research study?

"6 participants with intestinal transplantation aged 18 to 65 are being sought for this study. To qualify, patients must suffer from Tufting Enteropathy, Crohn's disease or Volvulus."

Answered by AI

Has the Federal Drug Administration sanctioned Cell Therapy?

"Due to the limited data available on efficacy and safety, our team at Power have assigned Cell Therapy a score of 1. This is because it is currently in Phase 1 clinical trials."

Answered by AI

Are participants aged above 30 admitted to this clinical research?

"As per the requirements for this clinical trial, eligible patients must be aged between 18 and 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation
2021. "Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04804891.
~4 spots leftby Dec 2028
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