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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04924491
Other study ID # THYTECH1-2018-005
Secondary ID 2018-003574-28
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 10, 2020
Est. completion date December 31, 2026

Study information

Verified date September 2023
Source Hospital General Universitario Gregorio Marañon
Contact Rafael Correa-Rocha, PhD
Phone +34 915866455
Email rafael.correa@iisgm.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Current transplant practice is far from guaranteeing the life expectancy of patients, particularly if the patients are children. THYTECH aims to revolutionize the field of clinical immunology developing a new approach to govern the regulatory skills of immune system, preventing graft rejection and opening a new frontier in the treatment of immune diseases. Transfer of regulatory T cells (Treg) has acquired growing interest in the race to achieve indefinite transplant survival. Up to now, the use of Treg therapy to prevent solid graft rejection in humans has demonstrated that this therapy is safe, but the clinical efficacy is limited. The small Treg numbers that can be purified from peripheral blood along with the low survival and limited suppressive capacity of differentiated Tregs obtained from adults have probably compromised the efficacy of this therapy. The investigators have developed an innovative approach to overcome current barriers and make Treg transfer a reality equipped to achieve indefinite graft survival. The major innovation of THYTECH is the employment of thymic tissue, the site of Treg generation, as a new source of Tregs to obtain massive amounts of thymus-derived Tregs (thyTreg) with very high purity (>95% of CD 25+ Foxp3+ cells) and improved survival and suppressive capacities. The investigators are recruiting patients in a clinical trial transferring autologous Tregs in heart-transplanted children to prevent graft rejection.


Recruitment information / eligibility

Status Recruiting
Enrollment 11
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility Inclusion Criteria: 1. Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant. 2. Patients without contraindication to immunosuppressive drugs. 3. 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 Exclusion Criteria: 1. Patients with DiGeorge Syndrome, since their thymic function is affected. 2. Human immunodeficiency virus positive serology 3. Epstein-Barr virus active infection 4. Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies 5. Patients with a history of previous malignancy 6. Patients who have participated in other intervention studies in the last month. 7. Patients who have received induction therapy with Basiliximab or Thymoglobulin. 8. Patients who have previously been thymectomized or transplanted. 9. Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes) 10. Patients who will receive an asystole heart

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Autologous thyTreg
Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)

Locations

Country Name City State
Spain Hospital General Universitario Gregorio Marañon Madrid

Sponsors (3)

Lead Sponsor Collaborator
Rafael Correa-Rocha Fundación Familia Alonso, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Repopulation of Treg cells in the patient, determined as the increase of Treg values in peripheral blood with respect to pre-transplant values or in comparison with a control cohort of non-treated patients. 24 months
Secondary Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography) that require treatment in the 2 years post-transplant 24 months
Secondary Number of Treg cells in peripheral blood 24 months
Secondary Change in the number of naive and memory Treg cells, and the production/levels of interferon gamma and interleukins (IL-4, IL-17A and IL-10). 24 months
Secondary Decrease of cell subsets related with rejection (CD8 T cells subsets, activated T cells, antibody-secreting B cells) during the post-transplant follow-up period. 24 months
Secondary Overall patient survival rate at 24 months. 24 months
Secondary Change on parameters of electrocardiogram (PR, QRS and corrected QT interval) of transplanted heart. 24 months
Secondary Change on parameters of echocardiogram (mitral and tricuspid regurgitation; mitral and tissue mitral Doppler; and tricuspid and tissue tricuspid Doppler ) of transplanted heart. 24 months
Secondary Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V4.03 criteria. 24 months
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