A Novel GMP Protocol to Produce High-Quality Treg Cells From the Pediatric Thymic Tissue to Be Employed as Cellular Therapy.
Esther Bernaldo-de-Quirós, Beatriz Cózar, Rocío López-Esteban...
https://pubmed.ncbi.nlm.nih.gov/35651624Actively Recruiting
Phase 1
Phase 2
Age: 0 - 2Years
All Genders
ID04924491
Randomized Phase I/II Trial Evaluating Autologous Treg Cell Transfer from Thymic Tissue to Prevent Rejection in Heart Transplant Children
Led by Rafael Correa-Rocha · Updated on 2025-02-03
11
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rafael Correa-Rocha
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of regulatory T cells obtained from thymic tissue (thyTreg) to prevent rejection in children undergoing heart transplantation. This phase I/II clinical trial aims to test the safety and effectiveness of transferring these autologous thyTreg cells, which have improved survival and suppressive capacities compared to Tregs isolated from adult blood. The study focuses on children under two years old who require heart transplants and seeks to improve long-term graft survival by leveraging thymus-derived Treg cells. Participants will receive one of two doses of autologous thyTreg cells: either 10 million or 20 million cells per kilogram. These cells are expanded and stimulated with interleukin-2 before transfusion. The study is randomized and exploratory, with no masking, and lasts for 24 months post-transplant. The trial builds on preclinical findings and involves the adoptive transfer of the patient's own thymus-derived Treg cells to prevent immune rejection. Throughout the 24 months following transplantation, participants will be closely monitored for Treg cell levels in their blood, incidence of acute myocardial rejection episodes, and changes in immune cell subsets and cytokine production. Heart function will be assessed through electrocardiogram and echocardiogram measurements. The research team will also track treatment-related adverse events and overall patient survival. This comprehensive follow-up will help determine the safety and immune effects of thyTreg therapy in young heart transplant recipients.
CONDITIONS
Brief Title
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
Who Can Participate
Age: 0 - 2Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patient under two years of age who meets all requirements to undergo a heart transplant
- No contraindication to immunosuppressive drugs
- Parent or guardian willing and able to understand the study and sign informed consent
You will not qualify if you...
- Diagnosis of DiGeorge Syndrome
- Positive for human immunodeficiency virus (HIV)
- Active Epstein-Barr virus infection
- Hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies
- History of previous malignancy
- Participation in other intervention studies in the last month
- Received induction therapy with Basiliximab or Thymoglobulin
- Previous thymectomy or heart transplantation
- Severe autoimmune disease such as celiac disease, autoimmune hypothyroidism, or autoimmune diabetes
- Recipient of an asystole heart
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Initial treatment period around the time of heart transplant
Participants receive autologous thyTreg cell transfer to help prevent rejection of the transplanted heart.
1 treatment visit (in-person)
Follow-up
Duration - Up to 24 months
Participants are monitored for up to 24 months after treatment to assess Treg cell repopulation, heart transplant rejection episodes, and overall health.
Regular follow-up visits during the 24 months post-transplant
Trial Site Locations
Total: 1 location
1
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain, 28007
Actively Recruiting
Loading map...
Research Team
R
Rafael Correa-Rocha, PhD
D
Diana Hernandez Florez, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here