Effect of BM-MSCs in DCD Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

The Efficacy and Safety of Bone Marrow-derived Mesenchymal Stem Cells in Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02561767
• Other study ID #: MSCs-KTx-DCD-150924
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: September 25, 2015
• Last updated: September 25, 2015
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: September 2015
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Changxi Wang, M.D., Ph.D
• Phone: 86-20-87333428
• Email: wangchx[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Tubular Necrosis
• Kidney Transplantation
• Kidney Tubular Necrosis, Acute

Intervention

Other:
• bone marrow-derived mesenchymal stem cells
BM-MSCs is harvested from third-party health volunteer donors.
• Saline
Saline as placebo of MSCs

Drug:
• Induction therapy (ATG or Basiliximab)
ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group.
• Maintenance therapy (Low-dose CNI + MPA + steroids)
Maintenance immunosuppressive therapy consists of low-dose tacrolimus and mycophenolic acid and steroids. Recipients receive the same maintenance therapy in both MSCs group and control group.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University	Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Peng Y, Ke M, Xu L, Liu L, Chen X, Xia W, Li X, Chen Z, Ma J, Liao D, Li G, Fang J, Pan G, Xiang AP. Donor-derived mesenchymal stem cells combined with low-dose tacrolimus prevent acute rejection after renal transplantation: a clinical pilot study. Transplantation. 2013 Jan 15;95(1):161-8. doi: 10.1097/TP.0b013e3182754c53. Erratum in: Transplantation. 2014 Mar 27;97(6):e37. Pan, Guanghui [added]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated glomerular filtration rate	eGFR at one month post-transplant	1 month	No
Secondary	Incidence of slow graft function		12 months	No
Secondary	Incidence of delayed graft function		12 months	No
Secondary	Proportion of normal renal function recovery		12 months	No
Secondary	Time to renal function recovery		12 months	No
Secondary	Patient survival		12 months	No
Secondary	Renal graft survival		12 months	No
Secondary	Incidence of acute rejection		12 months	No
Secondary	Severe adverse events		12 months	Yes
Secondary	Estimated glomerular filtration rate	eGFR up to 12 months post-transplant	12 months	No

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