Recruiting
Phase 1

VB Marrow Cell Infusion

Sponsor:

Stanford University

Code:

NCT04571203

Conditions

Immune Tolerance

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Combined Deceased Donor Kidney and Hematopoietic Cell Transplants

Study Details

Brief 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.

Conditions

Immune Tolerance

Study ID

NCT04571203

Start date

May 6, 2022

Status verified date

Jun, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

RECIPIENT INCLUSION CRITERIA:

1. Patient is ≥ 18 years old, and <65 years of age.
2. Has End Stage Renal Disease (ESRD) and is a de novo kidney transplant candidate part Stanford standard of care.
3. Listed with the Organ Procurement and Transplantation Network (OPTN) for deceased donor transplantation.
4. A serotypic (Human Leucocyte Antigen) HLA match with the donor of a least 1 locus in A, B or DR.
5. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year post transplant.
6. Females have a negative serum pregnancy test.
7. Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial.
8. No known contraindication to administration of rabbit ATG or low dose irradiation.

DONOR INCLUSION CRITERIA:

1. Brain dead donor aged ≥ 16 and ≤ 55
2. Organ Procurement Organization (OPO) consent for vertebral body procurement
3. Organ Procurement Organization consent for research
4. Projected cold ischemia time <24 hours.

Exclusion Criteria:

RECIPIENT EXCLUSION CRITERIA:

1. Known allergy to rabbit protein.
2. History of malignancy with the exception of non melanoma skin malignancy.
3. Pregnant woman or nursing mother.
4. Body weight >90kg or BMI >35.
5. 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.
6. EBV (Epstein Bar Virus)Ab positive donor to EBV Ab negative recipient.
7. Active bacterial, viral or fungal infection defined as currently taking medication for the infection.
8. Leukopenia (white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3).
9. 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.
10. Concern for alcohol or other substance abuse.
11. Kidney disease at high risk for post transplant recurrence: aHUS (atypical hemolytic- uremic syndrome) and C3 glomerulopathy
12. Panel reactive antibody (PRA) >80%.
13. Positive donor specific antibody (DSA).
14. Prior or combined organ transplant.
15. Patients with >5 pack year smoking history, smoking within 10 years of enrollment, or first degree relative with lung cancer.

DONOR EXCLUSION CRITERIA:

1. History of malignancy with the exception of non melanoma skin malignancy.
2. History of autoimmune disease.
3. Known medical diagnosis of Zika virus infection within the prior 6 months, including post mortem screening.
4. Serological evidence of HIV, Hepatitis B (surface antigen positive), or Hepatitis C infection.
5. Evidence of systemic infection.
6. Kidney Donor Profile Index (KDPI) > 70%.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I Study of Combined DD Kidney and HCT Transplant

Single arm Phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion

Interventions

Combined 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.

Primary outcome measure

  • Number of patients out of the total patients enrolled who received both the kidney and the bone marrow from the same donor. [ Time Frame: 6 months ]
  • Determine the dose of TBI that will support donor CD3 Tcell chimerism between 30-75% at 45 days post infusion [ Time Frame: day 45 ]

Central Contacts and Locations

Central contacts

Anika Tahsin, BS

atahsin@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94305

MSOB

Recruiting

Stanford, California, United States, 94305

Contacts

More Information

Sponsor

Stanford University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-07-01.