Effect of SVF Derived MSC in DCD Renal Transplantation
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Tan Jianming, MD PhD
- Phone Number: 8613375918000
- Email: tanjm156@yahoo.com
Study Contact Backup
- Name: Tan Jianming, MD PhD
- Phone Number: 13375918000
- Email: tanjm156@yahoo.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350025
- Recruiting
- Fuzhou General Hospital, Xiamen Univ
-
Contact:
- Xia Gao, MD
- Phone Number: 8618065102725
- Email: 38704163@qq.com
-
Principal Investigator:
- Jianming Tan, Professor
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old
- Patient is willing to receive a kidney from DCD
- 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:
- 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
- Patient with prior solid organ transplant or cell transplant (e.g. bone marrow or islet cell).
- 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
- Patient receiving a concurrent SOT (heart, liver, pancreas)
- ABO incompatible donor recipient pair or CDC crossmatch positive transplant
- 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
- Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
- Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
- Donors or recipients are known human immunodeficiency virus (HIV) infection
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)
- Recipients with any significant infection or other contraindication that would preclude transplant
- Recipients with a history of hypercoagulable state
- 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.
- Recipients with active peptic ulcer disease (PUD), chronic diarrhea, or gastrointestinal problem affect absorption
- Recipients with a history of cancer within the last 5 years (exception: non-melanoma skin cell cancers cured by local resection are permitted)
- Recipients with a chest radiograph (no more than 2 months prior to randomization) consistent with an acute lung parenchymal process and malignancy
- Recipients with a hypersensitivity to any study drugs
- Recipients who have used any investigational drug within 30 days prior to the Day 1 visit
- Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: SVF(Stromal Vascular Fraction) derived MSC transprlantation
transplantation of autologous SVF derived MSC to the recipients of DCD kidney transplant.
|
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
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Allograft survival
Time Frame: 1 year
|
Allograft survival at 1 year post transplant
|
1 year
|
|
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)
|
1 year
|
|
Incidence of Acute rejection
Time Frame: 1 year
|
Incidence of acute rejection (biopsy confirmed acute rejection)
|
1 year
|
|
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)
|
3 months
|
|
SAE (severe adverse effects)
Time Frame: 1 year
|
Incidence of death, allograft loss, and hospitalization due to infection at 1 year.
|
1 year
|
|
non-hematologic toxicities
Time Frame: 1 year
|
Incidence of grade 3 and above non-hematologic toxicities
|
1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Tan Jianming, MD, PhD, Fuzhou General Hospital
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- SVF-DCD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uremia
-
NCT01391884Completed
-
NCT01408797UnknownRenal Transplantation | Uremia
-
NCT01356433CompletedInflammation | Uremia
-
NCT02606955Unknown
-
NCT06249373Recruiting
-
NCT07189741Not yet recruitingHemodialysis | Uremia | Uremia; Chronic
Clinical Trials on SVFderived MSC transplantations
-
NCT04823000Completed
-
NCT07431645CompletedPilot Study of Radiation-Induced Xerostomia Treatment With Allogeneic Mesenchymal Stromal Stem CellsHead and Neck Cancer | Radiation-Induced Xerostomia
-
NCT01213186UnknownHuman Immunodeficiency Virus | Disorder of Immune Reconstitution
-
NCT01754454Unknown
-
NCT06823063Not yet recruiting
-
NCT01175655CompletedBronchiolitis Obliterans | Lung Transplantation
-
NCT02379442Terminated
-
NCT03564808UnknownSkin Pigmentation Over Contour Deformities of Face | Trauma, Rhomberg Disease
-
NCT02307435UnknownNon Union Fracture | Metaphyseal Fibrous Defect
-
NCT06722105Not yet recruiting