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Monoclonal Antibodies
Mesenchymal Stromal Cells + Immunosuppressants for Kidney Transplant Recipients (TEACH Trial)
Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serological evidence of prior Cytomegalovirus (CMV) infection if donor is CMV positive
Donors must have the ability to understand and provide informed consent for all study procedures including kidney transplant and bone marrow harvest
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years)
Awards & highlights
TEACH Trial Summary
This trial is testing whether it is safe to give a certain type of cell, called mesenchymal stromal cells (MSCs), to kidney transplant recipients. The combination of the immunosuppressive (anti-rejection) study drugs plus the MSCs might allow a kidney transplant recipient to slowly reduce and/or then completely stop all anti-rejection drugs, without rejection of their kidney (renal) allograft, a process called "immunosuppression withdrawal".
Who is the study for?
This trial is for adults needing a kidney transplant from a living donor who's not an exact tissue match. They must have immunity to Epstein-Barr and Cytomegalovirus (if the donor has it), meet organ sharing network criteria, and agree to use effective birth control. People with immune deficiencies, certain cancers, high-risk kidney diseases, or recent immunosuppressive drugs can't join.Check my eligibility
What is being tested?
The study tests if mesenchymal stromal cells (MSCs) are safe for kidney recipients and if they help reduce or stop anti-rejection drugs without organ rejection. It involves multiple anti-rejection medications like alemtuzumab, belatacept, sirolimus, mycophenolate acid/mofetil, prednisone.See study design
What are the potential side effects?
Potential side effects include increased risk of infections and cancer due to long-term immunosuppression. Specific drug-related risks range from blood cell changes with alemtuzumab to gastrointestinal issues with mycophenolate and possible diabetes or cholesterol problems with sirolimus.
TEACH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had CMV before, and my donor is CMV positive.
Select...
I understand and agree to all procedures, including kidney transplant and bone marrow harvest.
Select...
I am an adult approved for a kidney transplant from a living donor who is not an exact HLA match.
TEACH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants who Achieve Operational Tolerance
Secondary outcome measures
Antibodies
Frequency of Antibody-Mediated Chronic Rejection
Frequency of Select Adverse Events (AEs)
+8 moreTEACH Trial Design
2Treatment groups
Experimental Treatment
Group I: MSCs 10^5 cells/kg+anti-rejection drugsExperimental Treatment7 Interventions
If the first 3 infusions of 10^4 donor-derived Mesenchymal Stromal Cells (MSCs) cells/kg are well tolerated, this cohort of 2 participants will receive 12 infusions of 10^5 cells/kg every 4-weeks.
Group II: MSCs 10^4 cells/kg+anti-rejection drugsExperimental Treatment7 Interventions
The first dosing cohort of 2 participants will receive 12 infusions of 10^4 donor-derived Mesenchymal Stromal Cells (MSCs) cells/kg every 4-weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
alemtuzumab
2004
Completed Phase 4
~2760
belatacept
2017
Completed Phase 4
~280
sirolimus
2006
Completed Phase 4
~1510
prednisone
1999
Completed Phase 3
~10920
mycophenolate mofetil
2000
Completed Phase 3
~1730
Find a Location
Who is running the clinical trial?
PPDIndustry Sponsor
159 Previous Clinical Trials
36,907 Total Patients Enrolled
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,910 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,461 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had CMV before, and my donor is CMV positive.I am not pregnant and agree to use effective birth control during and for 18 months after treatment.I meet the standards for organ or bone marrow donation set by my hospital and regulatory bodies.I understand and agree to all procedures, including kidney transplant and bone marrow harvest.I do not have any immune deficiency or hepatitis.I haven't had cancer, except for certain skin cancers or cervical cancer, in the last 5 years.I do not have kidney diseases likely to come back.I don't have active tuberculosis and have treated any latent infection.I haven't had any donor-specific antibodies or taken immunosuppressive drugs in the last year.I have not taken any strong immune system suppressing drugs.I am an adult approved for a kidney transplant from a living donor who is not an exact HLA match.I have never donated blood to the recipient, don't have CMV if they are CMV negative, and I'm free from HIV, HCV, and HBV.
Research Study Groups:
This trial has the following groups:- Group 1: MSCs 10^4 cells/kg+anti-rejection drugs
- Group 2: MSCs 10^5 cells/kg+anti-rejection drugs
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What further investigations have been conducted concerning the effects of alemtuzumab?
"Currently, there are 626 alemtuzumab trials in progress with 124 of those being phase 3. The principal centre for these studies is Philadelphia, Pennsylvania yet investigations into this drug also take place at 18331 different sites worldwide."
Answered by AI
Are there vacancies left in this trial for participants?
"According to information on clinicaltrials.gov, recruitment for this medical trial is still active as of May 12th 2022 since it's inception in July 2018."
Answered by AI
What is the current size of this research cohort?
"Affirmative. As published on the clinicaltrials.gov website, this medical trial is presently recruiting patients; it was initially posted back in July 30th 2018 and had its last update on May 12th 2022. The research requires 6 people to take part at a single site."
Answered by AI
Has the Food and Drug Administration sanctioned alemtuzumab for medical use?
"Due to the limited data on alemtuzumab's safety and efficacy, our team at Power assigned it a score of 1."
Answered by AI
What pathologies is alemtuzumab usually prescribed for?
"Alemtuzumab is an approved therapeutic option for thyroiditis and a range of other conditions, such as ulcerative colitis, varicella-zoster virus acute retinal necrosis, and neurological disorders."
Answered by AI
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