A Study of Experimental Cellular Immunotherapy For Living Donor Kidney Transplants

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Age: 18 to 65 years old
Gender:
Any
Healthy Volunteers: No
Keywords: living donor kidney transplant, kidney transplant, kidney donor, Stem Cell
Type: Drug study, Phase 3
Target:
4 Participants
Investigator:
Description
The main goal of this research is to determine if the experimental medicine MDR 101 can help kidney transplant patients.

The study team will test if a single infusion of MDR 101 will create a state of “tolerance” in the kidney recipient. The study team wants to learn if this treatment will allow patients to minimize anti-rejection medications. They hope patients can stay off these medications for at least 2 years or longer.

MDR 101 is processed from blood stem cells from the same person that is the kidney donor. This study will help better understand the effects of this stem cell therapy on kidney transplantation and life after transplant.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Planned recipient of a first kidney allograft from an HLA-matched, living related donor
  • Age ≥18 and ≤65 years
  • Single solid organ recipient (kidney only)
  • ABO compatibility with donor Recipient

Exclusion criteria:

  • Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
  • Baseline positive donor-specific anti-HLA antibody testing
  • Is taking immunosuppressive therapy
  • Evidence of prior hepatitis B (HBV) or hepatitis C (HCV) Donor Inclusion Criteria:
  • HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling) relative of the prospective recipient participant
  • Age ≥18 and ≤65 years
  • Prepared to be a living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells Donor
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The main study will take place about 2 months pre-transplant and 1 month post-transplant for observation.
Recruitment period
From May 16, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Mary Beth Lawless
Research Topic
Conditions:
  • Kidney Transplant Rejection