renal recipients
Conditions
Interventions
Product Name: bone marrow derived mesenchymal stromal cells
Pharmaceutical Form: Infusion
INN or Proposed INN: mesenchymal stromal cells
CAS Number: n.a.
Current Sponsor code: n.a.
Other descriptive n
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female or male, aged between 18 and 75 years. 2. Subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure. 3. Recipients of a first kidney graft from a deceased, living-unrelated or non-HLA identical living related donor > 50 years of age. 4. Panel Reactive Antibodies (PRA) = 10%. 5. Patients must be able to adhere to the study visit schedule and protocol requirements. 6. If female and of child-bearing age, subject must be non-pregnant, non-breastfeeding, and use adequate contraception. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Double organ transplant recipient. 2. Biopsy proven acute rejection (according to the Banff criteria) after transplantation.* 3. Patients with evidence of active infection or abscesses (with the exception of an uncomplicated urinary tract infection) before MSC infusion.* 4. Patients suffering from hepatic failure.* 5. Patients suffering from an active autoimmune disease.* 6. Patients who have had a previous BM transplant. 7. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. 8. Use of any investigational drug after transplantation. 9. Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria.* 10. Subjects who currently an active opportunistic infection at the time of MSC infusion (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB, BK) after transplantation.* 11. 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. 12. Known recent substance abuse (drug or alcohol).* 13. Contraindications to undergo a BM biopsy. 14. Patients who are recipients of ABO incompatible transplants. 15. Cold ischemia time >30 hrs. 16. Patients with severe total hypercholesterolemia or total hypertriglyceridemia (patients on lipid lowering treatment with controlled hyperlipidemia are acceptable).*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A 6-month study of efficacy and safety comparing concentration-controlled Certican® with MSCs to Certican® with standard tacrolimus in renal transplant recipients Patients of the MSC treated groups will receive two doses of autologous bone marrow (BM) derived MSCs IV, 7 days apart, 6 and 7 weeks after transplantation in combination with Certican® (1.5 mg/day). 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). Doses of MSCs will be 1-2x106 million MSCs per/kg body weight. Patients in the control group will receive Certican® (1.5 mg/day) and standard dose tacrolimus (through levels 6-8 ng/ml after 6 weeks). The primary end point is to compare fibrosis by quantitative Sirius Red scoring of MSC treated and untreated groups at 6 months compared to 4 weeks post transplant. ;Secondary Objective: Composite end point efficacy failure (Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up) at 6 months; renal function measured by cGFR (MDRD formula and iohexol clearance) and proteinuria at 6 months; CMV and BK infection (viremia, disease and syndrome); adverse events; the presence of donor specific antibodies (DSA) and immune monitoring in the different treatment groups; to compare the progression of "subclinical" cardiovascular disease in the different treatment groups by assessing echocardiography and pulse wave velocity.;Primary end point(s): The primary end point is to compare fibrosis by quantitative Sirius Red scoring of MSC treated and untreated groups at 6 months compared to 4 weeks post transplant. ;Timepoint(s) of evaluation of this end point: 6 months after renal transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Composite end point efficacy failure (Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up) at 6 months; renal function measured by cGFR (MDRD formula and iohexol clearance) and proteinuria at 6 months; CMV and BK infection (viremia, disease and syndrome); adverse events; the presence of donor specific antibodies (DSA) and immune monitoring in the different treatment groups; to compare the progression of "subclinical" cardiovascular disease in the different treatment groups by assessing echocardiography and pulse wave velocity.;Timepoint(s) of evaluation of this end point: 6 months after transplantation, and time points in between as described in the protocol | — |
Countries
Netherlands
Contacts
Public ContactClinical trials information LUMC ne
LUMC
Outcome results
None listed