- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02492308
Induction With SVF Derived MSC in Living-related Kidney Transplantation
Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Living-Related Kidney Transplants: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Tan Jianming, MD, PhD
- Phone Number: 8613375918000
- Email: tanjm156@yahoo.com
Study Contact Backup
- Name: Gao Xia, MD
- Phone Number: 8659122859175
- Email: 38704163@qq.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350000
- Recruiting
- Xi er huan road No.156
-
Contact:
- Gao Xia, MD
- Phone Number: 8659122859175
- Email: 38704163@qq.com
-
Contact:
- Tan Jianming, MD, PhD
- Phone Number: 861337598000
- Email: doctortjm@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old 2. Patient is willing to receive a kidney from a certifiable living-relative donor 18-60 years of age 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:
- 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 with cardiac death (non-heart beating donor) 8 Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
9. Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B 10. Donors or recipients are known human immunodeficiency virus (HIV) infection 11. 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) 12. Recipients with any significant infection or other contraindication that would preclude transplant 13. Recipients with a history of hypercoagulabale state 14. 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.
15. Recipients with active peptic ulcer disease (PUD), chronic diarrhea, or gastrointestinal problem affect absorption 16. Recipients with a history of cancer within the last 5 years (exception: non-melanoma skin cell cancers cured by local resection are permitted) 17. Recipients with a chest radiograph (no more than 2 months prior to randomization) consistent with an acute lung parenchymal process and malignancy 18. Recipients with a hypersensitivity to any study drugs 19. Recipients who have used any investigational drug within 30 days prior to the Day 1 visit 20. 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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SVF-MSC induction
|
Procedure: infusion of autologous SVF derived MSC to the recipients of living-relative 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 |
Active Comparator: Basiliximab induction
The control group will be inducted with Basiliximab
|
The control group will be inducted with Basiliximab before living-relative kidney transplantation and on POD 4
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of autologous SVF derived MSC transplantation on reducing the dosage of immunosuppressant in living-related kidney transplant recipients.
Time Frame: 1 year
|
Reducing the dosage of immunosuppressant by 30% of CNI in living-related kidney transplant recipients.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in renal function
Time Frame: 1 year
|
• Changes in renal function as determined by estimated glomerular filtration rate (eGFR) and proteinuria (>1g) at 1 year post transplant
|
1 year
|
Incidence of acute rejection
Time Frame: 1 year
|
Incidence of acute rejection (biopsy confirmed acute rejection according to Banff creteria)
|
1 year
|
Incidence of delayed graft function
Time Frame: 1 month
|
Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)
|
1 month
|
Allograft survival
Time Frame: 1 year
|
Allograft survival at 1 year post transplant
|
1 year
|
Infection adverse event
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
|
Hematologic toxicities
Time Frame: 1 year
|
Incidence of grade 4 hematologic toxicities
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tan Jianming, MD PhD, Fuzhou General Hospital, Xiamen Univ
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVF-LR
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.
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