Clinical trial NCT02561767: Effect of BM-MSCs in DCD Kidney Transplantation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Kidney Transplantation
Acute Kidney Tubular Necrosis
Keywords: kidney transplantation
mesenchymal stem cell
donation after citizen's death
ischemia reperfusion injury
renal function recovery
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Guangzhou Medical University
First posted: 2015-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Estimated glomerular filtration rate
timeFrame: 1 month
Secondary outcomes:
measure: Incidence of slow graft function
timeFrame: 12 months
measure: Incidence of delayed graft function
timeFrame: 12 months
measure: Proportion of normal renal function recovery
timeFrame: 12 months
measure: Time to renal function recovery
timeFrame: 12 months
measure: Patient survival
timeFrame: 12 months
measure: Renal graft survival
timeFrame: 12 months
measure: Incidence of acute rejection
timeFrame: 12 months
measure: Severe adverse events
timeFrame: 12 months
measure: Estimated glomerular filtration rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Changxi Wang, M.D., Ph.D
role: STUDY_CHAIR
References:
citation: 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.