Clinical trials: Organ Donor
CMV Viremia, CMV Disease
Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease
This is an expanded access protocol designed to provide access of ATA230 to subjects with cytomegalovirus (CMV) viremia or disease, who are intolerant to, or failed, standard antiviral therapy and have no comparable treatment…
- Trial name
- NCT03010332
- Testing
- Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)
- Sponsor
- Atara Biotherapeutics
Heart Transplant
Donors After Circulatory Death Heart Trial
To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
- Trial name
- NCT03831048
- Testing
- OCS Heart System, Cold Storage
- Where
- 25 sites in United States
- Volunteers
- 180 people
- Sponsor
- TransMedics
Liver Preservation
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.
- Trial name
- REVIVE (NCT02449694)
- Testing
- OCS Liver
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- TransMedics
Lung Transplantation
OCS Lung System EXPAND II Trial
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
- Trial name
- NCT03343535
- Testing
- OCS Lung Preservation
- Where
- 14 sites in United States
- Volunteers
- 46 people
- Sponsor
- TransMedics
Kidney Transplantation
A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients
An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.
- Trial name
- FREEDOM-2 (NCT01649388)
- Testing
- FCR001
- Where
- 3 sites in United States
- Sponsor
- Talaris Therapeutics Inc.
Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor.
- Trial name
- NCT01974206
- Testing
- ASP0113
- Where
- 53 sites in United States, Australia and 4 more
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Heart Transplant
Donor After Circulatory Death Heart CAP Trial
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
- Trial name
- NCT04615182
- Testing
- Transplant
- Where
- 25 sites in United States
- Volunteers
- 90 people
- Sponsor
- TransMedics
Heart Transplant
International EXPAND Heart Pivotal Trial
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve…
- Trial name
- EXPANDHeart (NCT02323321)
- Testing
- Preservation of Hearts for Transplantation
- Where
- 11 sites in United States
- Volunteers
- 75 people
- Sponsor
- TransMedics
Transplant Rejection, Allograft Rejection
Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis…
- Conditions
- Transplant Rejection, Allograft Rejection, Complications
- Trial name
- SPARO (NCT03984747)
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Natera, Inc.
Cytomegalovirus (CMV) Infection, Kidney Transplantation
A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative…
- Trial name
- NCT03629080
- Testing
- HB-101 vaccine
- Where
- 25 sites in United States, Denmark and 4 more
- Volunteers
- 83 people
- Sponsor
- Hookipa Biotech GmbH
Organ Transplant, Ischemic Reperfusion Injury
PERTRIAL - Perla® Preservation Solution
Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.
- Trial name
- NCT05194306
- Testing
- Perla® Cold Preservation solution
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Advanced Life Solutions
Liver Transplant
OCS Liver PROTECT Continued Access Protocol
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
- Trial name
- NCT04186221
- Testing
- OCS Liver System
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- TransMedics
Liver Transplant
OCS Liver DCD Trial
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
- Trial name
- NCT04194437
- Testing
- OCS Liver System
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- TransMedics
Kidney Preservation and Transportation
Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation
TB1-K Device is an organ preservation and transportation system, using ultrasound technology with a cooling system to preserve the organ in optimal conditions during transport to the transplant recipient.
- Trial name
- EMERGE (NCT03600285)
- Testing
- TB1-K
- Where
- 3 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Transplant Biomedicals, S.L.
Organ Preservation
A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation
This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to…
- Trial name
- OPTIMAL (NCT06263023)
- Testing
- Sub-Normothermic Machine Preservation and Assessment
- Where
- 8 sites in United States
- Volunteers
- 80 people
- Sponsor
- 34 Lives, PBC
Advanced Heart Failure, Heart Transplantation
TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy
TORCH-LATAM-002 is a pragmatic stepped-wedge cluster randomized trial evaluating an integrated regional pathway for adults with advanced heart failure who require specialized heart transplant evaluation and a documented candidacy…
- Conditions
- Advanced Heart Failure, Heart Transplantation, Acquired Heart Disease
- Trial name
- TORCH-002 (NCT07836803)
- Testing
- TORCH Adult Heart Transplant Evaluation and Candidacy Pathway
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Transplanted Organ Rejection
A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation
A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.
- Trial name
- FREEDOM-1 (NCT03995901)
- Testing
- FCR001
- Where
- 18 sites in United States
- Volunteers
- 15 people
- Sponsor
- Talaris Therapeutics Inc.
Delayed Graft Function, Other Complications of Kidney Transplant
Biomarkers of Aging as Predictors of Kidney Transplant Function
The primary purpose of this study is to measure the correlation between baseline expression of aging biomarkers, SenesceTest in blood of organ donor and renal graft function.
- Trial name
- NCT02335333
- Testing
- No treatment
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Sapere Bio
Liver Transplantation, Liver Preservation for Transplant
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
- Trial name
- PROTECT (NCT02522871)
- Testing
- OCS™ Liver System, Control
- Where
- 20 sites in United States
- Volunteers
- 300 people
- Sponsor
- TransMedics
Lung Transplant
International EXPAND Lung Pivotal Trial
To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
- Trial name
- EXPANDLung (NCT01963780)
- Testing
- OCS Lung Preservation
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 79 people
- Sponsor
- TransMedics