Effect of SVF Derived MSC in DCD Renal Transplantation

• Status: Unknown status
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial is to determine if autologous Stromal Vascular Fraction (SVF) derived Mesenchymal Stem Cell (MSC) infusion during and after kidney transplantation from Donation after Citizen Death (DCD) can effectively reduce the need for post transplant immunosuppressant and elevate GFR of allograft. The investigators will infuse autologous SVF derived MSC to the recipients during and after operation to assess the effect of SVF derived MSC and closely monitor renal function, dosage of immunosuppressant, acute rejection, and graft survival. 120 patients eligible for the study as described below will be enrolled, with 60 patients in intervention group and 60 in control group.

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

Details

• Lead Sponsor: Fuzhou General Hospital
• Treatments: Antibodies, Monoclonal; Basiliximab

Criteria

Inclusion Criteria:

1. Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old

2. Patient is willing to receive a kidney from DCD

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. 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

2. Patient with prior solid organ transplant or cell transplant (e.g. bone marrow or islet cell).

3. Patient is deemed likely to have a second solid organ transplant or cell transplant (e.g. bone marrow or islet cell) in next 3 years

4. Patient receiving a concurrent SOT (heart, liver, pancreas)

5. ABO incompatible donor recipient pair or CDC crossmatch positive transplant

6. Sensitized patients (most recent anti-HLA Class I or II Panel Reactive Antibodies (PRA)>10% by a CDC-assay) or patients identified a high immunological risk by the transplant physician

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

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

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

10. Recipients at risk for tuberculosis (TB)

• Current clinical, radiographic or laboratory evidence of active or latent TB as determined by local standard of care

• History of active TB:

(I). Within the last 2 years, even if treated (II) Greater than 2 years ago, unless there is documentation of adequate treatment according to locally accepted clinical practice c. Recipients at risk of reactivation of TB precludes administration of conventional immunosuppressant (as determined by investigator and based upon appropriate evaluation)

11. Recipients with any significant infection or other contraindication that would preclude transplant

12. Recipients with a history of hypercoagulable state

13. 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.

14. Recipients with active peptic ulcer disease (PUD), chronic diarrhea, or gastrointestinal problem affect absorption

15. Recipients with a history of cancer within the last 5 years (exception: non-melanoma skin cell cancers cured by local resection are permitted)

16. Recipients with a chest radiograph (no more than 2 months prior to randomization) consistent with an acute lung parenchymal process and malignancy

17. Recipients with a hypersensitivity to any study drugs

18. Recipients who have used any investigational drug within 30 days prior to the Day 1 visit

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