Effect of BM-MSCs in DCD Kidney Transplantation

• Status: Unknown status
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to determine the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells in kidney transplantation from Chinese donation after citizen's death (DCD). A pair uremia patients receiving kidney grafts from a same donor are randomized into two groups: MSCs group and control group. Besides routine induction therapy (ATG or Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA + prednisone), patients in MSCs group are administered MSCs treatment (1*10^6/kg). Allogeneic bone marrow-derived MSCs (1*10^6/kg) are given intravenously at day 0 (post renal reperfusion during surgery), day 7, day 14 and day 21. The renal allograft function, rejection, patient/graft survival and severe adverse events within 12 months post-transplant are monitored.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Collaborator: Second Affiliated Hospital of Guangzhou Medical University
• Treatments: Antibodies, Monoclonal; Basiliximab; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

1. Primary kidney transplantation

2. Receiving induction therapy and combined immunosuppressive regimens (CNIs + MPA + steroids)

3. Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

Exclusion Criteria:

1. Secondary kidney transplantation

2. Combined or multi-organ transplantation

3. Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration

4. Panel reactive antibody (PRA)>20%

5. CDC crossmatch is positive

6. Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C

7. Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B

8. Donors or recipients are known human immunodeficiency virus (HIV) infection

9. Patients with active infection

10. Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow-up.

11. Patients with severe cardiovascular dysfunction

12. WBC<3*10^9/L or RBC <5g/dL

13. Highly allergic constitution or having severe history of allergies.

14. Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption

15. Patients with a history of cancer within the last 5 years

16. Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness