Advancing Regenerative Medicine

Stanford's Alpha Clinic supports the advancement of regenerative therapies in the following ways

Real World Consortium

We are pursuing real-world outcomes data in the post-CAR pediatric and adult settings.

Collaborate with the Alpha Clinic Network to develop a charter
Offer consultation on regulatory and IRB protocol best practices
Consult on development of tools and databases for sample tracking and real-world outcomes data analysis
Provide guidance on multi-site data sharing template agreements and standards

Expand Toxicity Guidelines and Safety

We are working with the Alpha Clinic network to build a California Cell Therapy Safety Monitoring Committee (CCTSMC)

Safety guidance for IITs conducted through the CIRM CLIN2 award mechanism and designated as “high-risk”. This includes first-in-human testing, first-in-child testing and therapy using genetically manipulated cells.
Develop best practices and guidelines for toxicity grading and management.
Offer consultation and expertise on safety-related issues, including serious adverse events (SAEs), subject deviations, internal and external audit/monitoring reports, dose escalation decisions based on available AEs and dose limiting toxicity (DLT) determinations, and study halt/termination based on protocol-specified safety rules.

Maintain a Minimum Number of Clinical trials

Current Cell and Gene Therapy Clinical Trial List:

Inducing Graft Tolerance in HLA Haplotype Matched Related and 3 Ag Matched Unrelated Living Donor Kidney Transplantation

This research study is to determine if donor blood stem cells given after living, related, HLA antigen (Ag) haplotype match or living, unrelated donor kidney transplantation. Minimal HLA antigen matching will include matching of 2 HLA antigens that can be either HLA A, B, and /or DR. This research will change the immune system such that immunosuppressive drugs can be completely withdrawn or reduced to minimal dose without kidney rejection.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

procedure: Immune tolerance after kidney transplant
drug: Donor blood stem cells and T cells

Eligibility

Inclusion Criteria:

1. All consenting adults (18 years of age) living donor renal transplant recipients at Stanford University Medical Center who have a one haplotype match donor.
2. Patients who agree to participate in the study and sign an Informed Consent.
3. Patients who have no known contraindication to administration of rabbit ATG or radiation.
4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 24 months posttranplant.

Exclusion Criteria:

1. Previous treatment with rabbit ATG or known allergy to rabbit proteins.
2. History of malignancy with the exception of non-melanoma skin malignancies.
3. Pregnant women or nursing mothers.
4. Serological evidence of HIV, Hepatitis B or Hepatitis C infection.
5. Seronegative for Epstein-Barr virus , if donor is seropositive.
6. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3)
7. Panel Reactive antibody greater then 20% or demonstration of donor specific antibody (DSA).
8. Prior organ transplantation.
9. High risk of primary kidney disease recurrence (i.e. primary FSGS).

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

ALL

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Asha Shori, CCRP
650-736-0245
Not Recruiting

Link to All Stanford Clinical Trials

Stanford Affiliates

The Alpha Clinic Network

We are part of a state-wide network funded by the California Institute for Regenerative Medicine

This network includes:

Find a doctor

Clinics & Services

Research Resources

Professional Training

Education Resources

CGT Career Development