The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation - M reg Trial

Phase 1

Active, not recruiting

• Conditions: Kidney allograft rejection following living-donor renal transplantation.; MedDRA version: 17.0 Level: LLT Classification code 10051366 Term: Kidney graft dysfunction System Organ Class: 100000004863; MedDRA version: 17.0 Level: LLT Classification code 10049581 Term: Graft rejection episode System Organ Class: 100000004870; MedDRA version: 17.0 Level: LLT Classification code 10069030 Term: Graft failure System Organ Class: 100000004863; MedDRA version: 17.0 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 100000004865; MedDRA version: 17.0 Level: LLT Classification code 10038297 Term: Rejection acute renal System Organ Class: 100000004870; MedDRA version: 17.0 Level: LLT Classification code 10021510 Term: Immunosuppression NOS System Organ Class: 100000004870; MedDRA version: 17.0 Level: LLT Classification code 10038299 Term: Rejection chronic renal System Organ Class: 100000004863; MedDRA version: 17.0 Level: LLT Classification code 10066543 Term: Acute allograft rejection System Organ Class: 100000004870; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-000999-15-DE
• Lead Sponsor: niversity Hospital Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-06
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

The main inclusion criteria for trial patients (organ recipients) are:

• Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
• Aged at least 18 years
• Signed and dated written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

The main exclusion criteria for trial patients (organ recipients) are:

• Patient has previously received any tissue or organ transplant other than the planned kidney graft
• Known contraindication to the protocol-specified treatments / medications
• Genetically identical to the prospective organ donor at the HLA loci
• PRA grade > 40% within 6 months prior to enrolment
• Previous treatment with any desensitisation procedure (with or without IVIg)
• Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin)
• Evidence of significant local or systemic infection
• HIV-positive, EBV-negative or suffering chronic viral hepatitis
• CMV-negative and receiving a kidney from a CMV-positive donor
• Significant liver disease (persistently elevated AST and/or ALT levels > 2 x ULN)
• Malignant or pre-malignant haematological conditions
• Known IgA or IgG deficiency
• Any pro-coagulant disposition, as evidenced by a past history of thromboembolic disease or abnormal laboratory coagulation parameters which, in the judgement of the Investigator, would place the subject at undue risk
• Previous history of transfusion-associated disease which, in the judgement of the Investigator, would place the subject at undue risk
• Any condition resulting in a substantial reduction in the volume of the pulmonary vasculature or an increase in the pulmonary vascular resistance. Any disease or disease process leading to substantially elevated pulmonary arterial pressure (as evidenced by electrocardiography, echocardiography, radiology or cardiac catheterisation) or right heart hypertrophy or dysfunction
• Known atrial or ventricular septal defects posing a risk of paradoxical embolism of infused cells or cell aggregates
• Known hypersensitivity to any component of the cell product or components used in the manufacture of the cell product.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified