NCT04571203 · Stanford University
Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment
What this study is about
This is a single treatment group$1 phase 1 non randomly assigned dose finding study for safety, feasibility and effectiveness of deceased donor vertebral body (VB) marrow cell infusion and kidney transplantation.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- RECIPIENT INCLUSION CRITERIA:
- 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. DONOR INCLUSION CRITERIA:
- 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 criteria
- RECIPIENT EXCLUSION CRITERIA:
- 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. DONOR EXCLUSION CRITERIA:
- 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%.
Where
- Palo Alto, California
- Stanford, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations