Fibrosis Clinical Trial
Official title:
Autologous Bone Marrow Derived Mesenchymal Stromal Cell Therapy in Combination With Everolimus to Preserve Renal Structure and Function in Renal Recipients
This study will test the hypothesis that MSCs in combination with Everolimus facilitate Tacrolimus withdrawal, reduce fibrosis and decrease the incidence of opportunistic infections compared to standard tacrolimus dose.
Kidney transplantation has improved survival and quality of life for patients with end-stage
renal disease. Despite excellent short-term results, long-term survival of transplanted
kidneys has not improved accordingly in the last decades. Calcineurin inhibitors (CNI) have
been the cornerstone of immunosuppressive therapy for many years, due to their efficacy in
preventing acute rejection. However, CNI have nephrotoxic side effects that can directly
contribute to renal dysfunction and compromise long-term outcomes. Consequently there is a
strong interest in immunosuppressive (IS) regimens that maintain efficacy for the prevention
of acute rejection, whilst reducing nephrotoxicity.
In this perspective the combination of mesenchymal stromal cells (MSCs) with a mTor inhibitor
(Everolimus (Certican®)) might be an optimal strategy to facilitate CNI (tacrolimus)
withdrawal. MSCs have IS properties and roles in tissue repair and everolimus is a
proliferation signal inhibitor with potent immunosuppressant effects. In experimental studies
the combination of mTor inhibitor and MSCs was shown to attenuate alloimmune responses and to
promote allograft tolerance.
In total 70 de novo renal recipients, 18-75 years of ages will be recruited from the
transplant clinics of the LUMC. Thirty five of these patients will be included in the
Certican/ and MSC group and 35 patients in the Certican/ standard dose tacrolimus group.
Patients of the MSC treated groups will receive two doses of autologous BM derived MSCs IV, 7
days apart, 6 and 7 weeks after transplantation in combination with Certican® (1.5 mg
b.i.d.). At the time of the second MSC infusion tacrolimus will be withdrawn in 2 weeks
(after 1 week dose of tacrolimus will be halved, after 2 weeks stopped). Patients in the
control group will receive Certican® (1.5 mg b.i.d.) and standard dose tacrolimus (through
levels 6-8 ng/ml after 6 weeks).
Primary goal is evaluate whether concentration-controlled Certican® with MSCs compared to
Certican® with standard tacrolimus in renal transplant recipients reduces fibrosis by
quantitative Sirius Red scoring.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05570058 -
Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
Completed |
NCT03979417 -
Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic Targets
|
||
Completed |
NCT02408744 -
Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00148837 -
Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis
|
Phase 2 | |
Recruiting |
NCT05661123 -
Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis
|
N/A | |
Recruiting |
NCT04795570 -
Urethral Stricture After Transurethral Resection of the Prostate/Bladder: a Prospective Study of Risk Factors
|
||
Active, not recruiting |
NCT05075785 -
Covid-19 Respiratory Sequelae French Cohort
|
||
Recruiting |
NCT03308916 -
Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
|
N/A | |
Recruiting |
NCT05459259 -
Physiotherapy for Arthrofibrosis Following Knee Replacement.
|
||
Enrolling by invitation |
NCT01483248 -
Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis
|
Phase 1/Phase 2 | |
Completed |
NCT00001729 -
Combination Drug Therapy for Patients With Hepatitis C
|
Phase 3 | |
Completed |
NCT02049307 -
Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
|
Phase 2 | |
Active, not recruiting |
NCT05685823 -
The Impact of Conventional Hemodialysis and Renal Transplantation on the Global Longitudinal Strain of the Left Ventricle
|
||
Completed |
NCT00744939 -
Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist
|
Phase 4 | |
Completed |
NCT00252642 -
Peginterferon Alpha-2a Maintenance Therapy for Portal Hypertension in Patients With Hepatitis C
|
N/A | |
Recruiting |
NCT04934202 -
Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France
|
||
Completed |
NCT02774161 -
B-mode Ultrasound Imaging in Detecting Early Liver Cancer
|
N/A | |
Completed |
NCT02604862 -
Imaging FIB ONE in the Human Lung Using Endomicroscopy
|
Early Phase 1 | |
Active, not recruiting |
NCT01246388 -
Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy
|
N/A | |
Completed |
NCT02161952 -
Pirfenidone, an Antifibrotic and Antiinflammatory Drug
|
Phase 2 |