Organ Transplantation Clinical Trial
— MeasureOfficial title:
Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Allograft Rejection After Renal Transplantation
The purpose of the study is to test the safety and feasibility of autologous mesenchymal stem cell therapy in HLA-DR mismatched patients with subclinical rejection and or an increase in IF?TA in the renal biopsy 4 weeks or 6 months after renal transplantation.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Subject is willing to participate in the study and has signed the informed consent. - Recipients of a first kidney graft from a living HLA-DR mismatched donor (2 HLA-DR mismatches). - Subjects included in the study must have kidney biopsy proven SCR 4 weeks after transplantation. - Patients must be on triple immunosuppressive therapy of prednisone, CsA or tacrolimus and MMF according to current protocol. - Panel Reactive Antibodies (PRA) = 5%. - Patients must be able to adhere to the study visit schedule and protocol requirements. - If female and of child-bearing age, subject must be non-pregnant, non-breastfeeding, and use adequate contraception. - Patients must be able to give informed consent and the consent must be obtained prior to any study procedure. Exclusion Criteria: - Double organ transplant recipient. - Acute clinical rejection after transplantation. - Patients with evidence of active infection or abcesses before MSC infusion. - Patients suffering from hepatic failure. - Patients suffering from an active autoimmune disease. - Patients who have had a previous BM transplant. - A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. - Use of any investigational drug after transplantation. - Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria. - Subjects who currently have an active opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB) after transplantation. - Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) according to current transplantation inclusion criteria. - Known recent substance abuse (drug or alcohol). - Contraindications to undergo a BM biopsy. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden Universitary Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary 1 Safety: rate of (serious) adverse events in the study population 2 Feasibility: determination of the number of expanded MSCs in relation to the amount of BM collected, number of passages required and time to reach study target doses | 2 years | Yes | |
Secondary | Secondary endpoints: 1 Presence of late acute rejection (in the 6 month biopsy compared with the 4 week biopsy). 2 Sirius red staining for renal cortical matrix accumulation. 3 Immunologic response before and after MSC infusion. | 2 years | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT00987103 -
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
|
Phase 1 | |
Completed |
NCT03699839 -
Reducing the Burden of Influenza After Solid-Organ Transplantation
|
Phase 2/Phase 3 | |
Completed |
NCT01633424 -
The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT)
|
||
Completed |
NCT01254955 -
Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients
|
N/A | |
Completed |
NCT00948883 -
Study of Cancers After Solid Organs Transplants
|
N/A | |
Recruiting |
NCT02314949 -
Leuven Tolerogenic Protocol for Intestinal Transplantation
|
N/A | |
Recruiting |
NCT01283295 -
Immune Monitoring and Assay Development in Organ Transplant Recipients
|
||
Not yet recruiting |
NCT03861962 -
Re-evaluation of Donor-specific Anti-HLA Alloantibodies Immunoassay After Organ Transplantation, From Antigen Level to Epitope Level
|
||
Completed |
NCT01123187 -
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
|
N/A | |
Completed |
NCT00213304 -
The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation
|
Phase 3 | |
Completed |
NCT01515072 -
Remote Ischemic Preconditioning in Neurological Death Organ Donors
|
N/A | |
Completed |
NCT00904579 -
Cancer Risk in Organ Transplant Recipients and End-Stage Renal Disease
|
||
Recruiting |
NCT04687865 -
Constitution of a Biobank for Studies Related to Organ Transplantation (Lyon Centaure Biocollection)
|
||
Recruiting |
NCT00611494 -
Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors
|
Phase 4 | |
Completed |
NCT02852902 -
Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.
|
||
Completed |
NCT05685888 -
Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation
|
||
Recruiting |
NCT00792064 -
Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation
|
N/A | |
Completed |
NCT00286871 -
Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen
|
Phase 1 | |
Recruiting |
NCT03997253 -
Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management
|
N/A | |
Recruiting |
NCT01256931 -
Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.
|
N/A |