Actively Recruiting
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
Led by Rafael Correa-Rocha · Updated on 2025-02-03
11
Participants Needed
1
Research Sites
329 weeks
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
The investigators developed a protocol to isolate Treg cells from thymic tissue (thyTreg) discarded in pediatric cardiac surgeries. After completing the pre-clinical studies, the investigators have initiated a phase I/II clinical trial to test the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children. Condition or disease: Heart Transplantation Intervention/treatment: Regulatory T Cell (Treg) Infusion
CONDITIONS
Official Title
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant.
- Patients without contraindication to immunosuppressive drugs.
- Parents and/or guardians must be willing and able to understand the purpose and risks of the study and must sign the informed consent document
You will not qualify if you...
- Patients with DiGeorge Syndrome, since their thymic function is affected.
- Human immunodeficiency virus positive serology
- Epstein-Barr virus active infection
- Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies
- Patients with a history of previous malignancy
- Patients who have participated in other intervention studies in the last month.
- Patients who have received induction therapy with Basiliximab or Thymoglobulin.
- Patients who have previously been thymectomized or transplanted.
- Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)
- Patients who will receive an asystole heart
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain, 28007
Actively Recruiting
Research Team
R
Rafael Correa-Rocha, PhD
CONTACT
D
Diana Hernandez Florez, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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