Safety and Efficacy of MCA-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients: The Nereid Study*

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 16

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 living-unrelated or non-HLA
identical living related donor.
If a donor is > 50 years of age, recipient must be >25 years of age.
4. Panel Reactive Antibodies (PRA) <= 10%.
5. No HLA repeated mismatch between MCA-derived MSC and the HLA mismatch
between kidney graft and recipient.
6. Patients must be able to adhere to the study visit schedule and protocol
requirements.
7. If female and of child-bearing age, subject must be non-pregnant,
non-breastfeeding,
and use adequate contraception.

Exclusion Criteria

1. Double organ transplant recipient.
2. Biopsy proven acute rejection (according to the Banff criteria) in the first
6 weeks 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 have an active opportunistic infection at the time
of MCA-derived 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. Patients who are recipients of ABO incompatible transplants.
14. Cold ischemia time >30 hrs.
15.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).
16. Repeated HLA mismatch present between the MCA-derived MSC and the
mismatches between donor and kidney graft

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is the incidence of BPAR/graft loss after MCA-derived MSC<br /><br>treatment </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Renal function by calculated GFR , eGFR (CKD-EPI formula) and iohexol<br /><br>clearance<br /><br>- CMV and BK infection (viremia, disease and syndrome and subtype of BK).<br /><br>- Donor specific HLA sensitization by luminex before and after MSC infusions<br /><br>- Immune monitoring before and after MSC treatment<br /><br>- Incidence and severity of reported SAEs and AEs at 12 months</p><br>