Your session is about to expire
← Back to Search
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 belowSelect...
I have a severe intestinal disorder affecting nutrient absorption.
Select...
I have Short Bowel Syndrome from surgery, injury, or a specific condition.
Select...
I am between 18 and 65 years old.
Select...
I can sign the consent form by myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years after transplantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years after transplantation
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
1,447 Previous Clinical Trials
2,531,543 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Short Bowel Syndrome from surgery, injury, or a specific condition.I can attend all study visits for the next 4 years.My cancer has spread, but it's not a neuro-endocrine tumor.I have a severe intestinal disorder affecting nutrient absorption.I have multiple organ failure and have received a CD34+ cell infusion.I am older than 65.I have a slow-growing tumor or a condition that affects my abdomen, or I have kidney issues affecting my treatment options.I have severe brain swelling shown by MRI or CT scan results.I am between 18 and 65 years old.I show signs that might indicate graft-versus-host disease.I do not need medication to maintain my blood pressure.My doctors believe my physical function is severely limited with little chance of improvement.I can sign the consent form by myself.I do not need machines to help with my blood pressure or breathing.I am not using, nor willing to use, birth control during the trial.You have a condition that weakens your immune system.I experienced moderate or severe rejection before day 11 after my transplant.I have had a stem cell transplant before.I do not have a severe infection causing unstable blood pressure.I have high blood pressure, diabetes with HbA1c > 8, or seizures that are not well-controlled.You have been addicted to drugs or alcohol in the past six months.
Research Study Groups:
This trial has the following groups:- Group 1: Cell Therapy
- Group 2: Control
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger