Effect of SVF Derived MSC in DCD Renal Transplantation
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|ClinicalTrials.gov Identifier: NCT02492490|
Recruitment Status : Unknown
Verified November 2014 by Fuzhou General Hospital.
Recruitment status was: Recruiting
First Posted : July 8, 2015
Last Update Posted : July 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Uremia||Other: SVFderived MSC transplantations Drug: Basiliximab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2016|
Experimental: SVF(Stromal Vascular Fraction) derived MSC transprlantation
transplantation of autologous SVF derived MSC to the recipients of DCD kidney transplant.
Other: SVFderived MSC transplantations
infusion of autologous SVF derived MSC to the recipients of DCD kidney transplant.
Subjects with uremia in the intervention group will undergo puncture to collect SVF, then SVF will be cultured to abstain MSC, and the abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD. And the induction therapy of control group will be Basiliximab.
Active Comparator: Basiliximab
induction with Basiliximab during kidney transplantation from DCD
induction with Basiliximab before kidney transplantation and on POD 4
- Effects of autologous SVF derived MSC transplantation on reducing the dosage of CNI by 30% in Kidney Transplantation from Chinese Donation after Citizen Death [ Time Frame: 1 years ]Changes of the immunosuppressant by reducing 30% of CNI dosage.
- Changes in renal function as determined by eGFR and proteinuria [ Time Frame: 1 year ]Changes in renal function as determined by estimated glomerular filtration rate (eGFR) and proteinuria (>1g)
- Incidence of Acute rejection [ Time Frame: 1 year ]Incidence of acute rejection (biopsy confirmed acute rejection)
- Incidence of delayed graft function (DGF) [ Time Frame: 3 months ]Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)
- Allograft survival [ Time Frame: 1 year ]Allograft survival at 1 year post transplant
- SAE (severe adverse effects) [ Time Frame: 1 year ]Incidence of death, allograft loss, and hospitalization due to infection at 1 year.
- non-hematologic toxicities [ Time Frame: 1 year ]Incidence of grade 3 and above non-hematologic toxicities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492490
|Contact: Tan Jianming, MD PhDfirstname.lastname@example.org|
|Contact: Tan Jianming, MD PhDemail@example.com|
|Fuzhou General Hospital, Xiamen Univ||Recruiting|
|Fuzhou, Fujian, China, 350025|
|Contact: Jianming Tan, professor 008613375918000 firstname.lastname@example.org|
|Contact: Xia Gao, MD 8618065102725 email@example.com|
|Principal Investigator: Jianming Tan, Professor|
|Study Director:||Tan Jianming, MD, PhD||Fuzhou General Hospital|