Kidney transplant with donor vertebral body marrow to promote engraftment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, single-arm study enrolls adults with ESRD undergoing deceased donor kidney transplantation. After standard transplant procedures, participants receive low-dose irradiation and anti-thymocyte globulin conditioning, followed by an infusion of donor vertebral body marrow cells to promote hematopoietic engraftment. Immunosuppression includes steroids, MMF, and tacrolimus per standard care, with withdrawal from therapy if criteria are met. The trial aims to assess safety, feasibility, and preliminary signals of efficacy for achieving engraftment and potential tolerance. Enrollment is at Stanford University in Palo Alto, CA.

Why it matters

Who can join: the full rules

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%.

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting
• Msob
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Robert Lowsky, MD — Stanford University
• Study coordinator: Carlos Lazarte, B.A.
• Email: lazarte6@stanford.edu
• Phone: 6505548610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.