Status:
ACTIVE_NOT_RECRUITING
Mesenchymal Stromal Cells in Living Donor Kidney Transplantation
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Renal Transplantation
Mesenchymal Stem Cells
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a...
Detailed Description
The study is a double-blind, randomized, controlled, dose-escalation and safety study of the investigational product, autologous MSCs, to be assessed for inducing immune suppression in living donor ki...
Eligibility Criteria
Inclusion
- Males and females from 18 to 65 years of age
- Planned to receive a primary kidney transplant from a living donor
- Low immunologic risk defined as
- No history of current or historical antidonor human leukocyte antigen (HLA) antibodies (DSA)
- Panel of Reactive Antibodies (PRA) \<20%, historical
- Low risk for thrombotic events and normal prothrombin time, international normalized ratio (INR) and partial thromboplastin time
- Women of child bearing potential have a negative serum pregnancy test prior to transplantation
- Women of child bearing potential (including perimenopausal women who have had a menstrual period within the previous 1 year) who agree to use 2 forms of effective birth control regimen (at least one of which is a barrier method) throughout the study period and for 6 weeks following the end of the study or the last dose of mycophenolate mofetil, whichever comes first.
- In the opinion of the investigator, the subject is capable of understanding and complying with the protocol.
- Subjects must have signed the informed consent document prior to performance of any study related procedure including screening procedure.
Exclusion
- Recipient of multiple organ transplantation or scheduled for multiple organ transplantation
- Recipient with a donor-specific anti-HLA antibody or positive cross-match requiring deviation from standard immunosuppressive therapy
- Hepatitis C antibody positive, Hepatitis B antigen positive, or Hepatitis B core antibody positive
- Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrollment into this study
- Concurrent sepsis or active bacterial infection
- In the opinion of the investigator is anatomically a high-risk renal transplant with higher chance for thrombosis or bleeding
- Have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been treated
- Women of child bearing potential who are breastfeeding
- History of HIV infection
- Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
- Subject is not deemed medically stable for the study in the opinion of the Investigator or the subject's nephrologist.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03478215
Start Date
December 1 2016
End Date
December 1 2026
Last Update
March 14 2025
Active Locations (1)
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1
Houston Methodist Hospital System
Houston, Texas, United States, 77030