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Recruiting
NCT05900401
Delayed Tolerance Through Mixed Chimerism
Conditions: Kidney Failure, Kidney Transplant; Complications, Chimera
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 20
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
Summary
This study will examine the safety and effectiveness of a bone marrow transplant after kidney transplant (from either a living or deceased donor). An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system
Eligibility Criteria
Recipient Inclusion Criteria
1. Male or female 18-65 years of age.
2. Kidney transplant recipients from either LD or DD, with cryo-preserved HSCs available, good renal function (GFR\>60 ml/min/1.73m2), normal current allograft biopsy, and no history of documented rejection episodes.
3. First or second renal transplant.
4. Use of FDA-approved methods of contraception (those with less than a 3% failure rate) by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation. (For further information on FDA- approved methods of contraception, see https://www.fda.gov/media/150299/download
5. Ability to understand and provide informed consent.
6. Negative COVID-19 test during screening and two days prior to HSC transplantation (HSCT).
Deceased Donor (DD)
1. Male or female 18-70 years of age.
2. Consent to donate vertebral bones is obtained from the donor family.
3. HSCs are successfully cryopreserved and saved \>2X106/kg (CD34+ cells) of the recipient.
4. Acceptable laboratory parameters (hematology in normal or near-normal range. Liver function \
Source: ClinicalTrials.gov (NCT05900401). StuddyBuddy aggregates publicly available trial information.