Ignite Creation Date:
2024-05-06 @ 7:14 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02492490
Status:
UNKNOWN
Last Update Posted:
2015-07-08
First Post:
2015-05-20
Brief Title:
Effect of SVF Derived MSC in DCD Renal Transplantation
Sponsor:
Fuzhou General Hospital
Organization:
Fuzhou General Hospital
Study Overview
Official Title:
Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Kidney Transplantation From Chinese Donation After Citizen Death DCD A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The objective of this trial is to determine if autologous SVF derived MSC can effectively reduce the need for post transplant immunosuppressant in DCD kidney transplantation Emphasis will be placed on the safety of autologous SVF derived MSC infusion dosage of immunosuppressant GFR percentage of acute rejection 120 patients eligible for the study as described below will be enrolled with 60 patients in intervention group and 60 in control group Kidneys from the same donor of DCD will be random allocated to intervention group and control group In intervention group the investigators will collect SVF from recipients with special instruments before transplantation and culture SVF to abstain MSC The abstained MSC will be infused to the recipients of DCD kidney transplantation during operation and on 7 14 21 POD The investigators will assess whether induction therapy with autologous SVF derived MSC is feasible in DCD kidney transplantation The effectiveness of autologous SVF derived MSC induction therapy on reducing of immunosuppressant reducing the rate of rejection elevating patient and allograft survival improving allograft function from day 0 to 12 months after transplantation Additionally the investigators will assess the percentage of acute rejection or antibody mediated rejection by Banff criteria the incidence of delayed graft function defined as the need for post-transplant dialysis within one week and the incidence of adverse events including infection grade 3 and above non-hematologic toxicities and grade 4 hematologic toxicities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None