Mesenchymal Stromal Cell Therapy in Renal Recipients

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• 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.

• Recipients of a first kidney graft from a deceased, living-unrelated or non-HLA identical living related donor > 50 years of age.

• Panel Reactive Antibodies (PRA) ≤ 10%.

• 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.

Exclusion Criteria:

• Double organ transplant recipient.

• Biopsy proven acute rejection (according to the Banff criteria) in the first 6 weeks after transplantation.

• Patients with evidence of active infection or abscesses (with the exception of an uncomplicated urinary tract infection) 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 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.

• 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.

• Patients who are recipients of ABO incompatible transplants.

• Cold ischemia time >30 hrs.

• Patients with severe total hypercholesterolemia (>7.5 mmol/L) or total hypertriglyceridemia (>5.6 mmol/L) (patients on lipid lowering treatment with controlled hyperlipidemia are acceptable).