RecruitingPhase 1NCT04571203

Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment

Phase I Study of Combined Deceased Donor Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment

Sponsor

Stanford University

Enrollment

30 participants

Start Date

May 6, 2022

Study Type

INTERVENTIONAL

Conditions

Immune Tolerance

Summary

This is a single arm phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion and kidney transplantation.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria12

Patient is ≥ 18 years old, and <65 years of age.
Has End Stage Renal Disease (ESRD) and is a de novo kidney transplant candidate part Stanford standard of care.
Listed with the Organ Procurement and Transplantation Network (OPTN) for deceased donor transplantation.
A serotypic (Human Leucocyte Antigen) HLA match with the donor of a least 1 locus in A, B or DR.
Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year post transplant.
Females have a negative serum pregnancy test.
Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial.
No known contraindication to administration of rabbit ATG or low dose irradiation.
Brain dead donor aged ≥ 16 and ≤ 55
Organ Procurement Organization (OPO) consent for vertebral body procurement
Organ Procurement Organization consent for research
Projected cold ischemia time <24 hours.

Exclusion Criteria21

Known allergy to rabbit protein.
History of malignancy with the exception of non melanoma skin malignancy.
Pregnant woman or nursing mother.
Body weight >90kg or BMI >35.
Evidence of HIV 1/2 antibody (Ab), HTLV 1 and HTLV 2 Ab (Human T-Lymphotropic Virus), Hepatitis B sAg (surface antigen), Hepatitis C Ab, or positive syphilis screen.
EBV (Epstein Bar Virus)Ab positive donor to EBV Ab negative recipient.
Active bacterial, viral or fungal infection defined as currently taking medication for the infection.
Leukopenia (white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3).
Psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the Stanford Transplant team caring for this potential patient would place the patient at an unacceptable risk.
Concern for alcohol or other substance abuse.
Kidney disease at high risk for post transplant recurrence: aHUS (atypical hemolytic- uremic syndrome) and C3 glomerulopathy
Panel reactive antibody (PRA) >80%.
Positive donor specific antibody (DSA).
Prior or combined organ transplant.
Patients with >5 pack year smoking history, smoking within 10 years of enrollment, or first degree relative with lung cancer.
History of malignancy with the exception of non melanoma skin malignancy.
History of autoimmune disease.
Known medical diagnosis of Zika virus infection within the prior 6 months, including post mortem screening.
Serological evidence of HIV, Hepatitis B (surface antigen positive), or Hepatitis C infection.
Evidence of systemic infection.
Kidney Donor Profile Index (KDPI) > 70%.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCombined Deceased Donor Kidney and Hematopoietic Cell Transplants

This combined kidney and hematopoietic cell transplants with a conditioning regimen with irradiation and ATG creates an environment of immune-tolerance. This promotes hematopoietic cell engraftment.