Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

NCT05086003 | Recruiting Phase 2

• 1 other identifier: 0759-15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.

Conditions

Renal Transplantation

Keywords

Renal transplantation; Bone marrow transplantation; Immune tolerance; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.

  Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.

  12 months

Study Arms (1)

Kidney and bone marrow transplantation

EXPERIMENTAL

Combined kidney and bone marrow transplantation after preparation with thymoglobuline and total lymphoid irradiation

Combination Product: Combined kidney and bone marrow transplantation

Interventions

Combined kidney and bone marrow transplantation COMBINATION_PRODUCT

Combined kidney and bone marrow transplantation

Kidney and bone marrow transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18 years
• Matched siblings
• No contra-indication to thymoglobuline or total lymphoid irradiation

You may not qualify if:

• Pregnant women or breast feeding
• Infection with HIV, HBV or HCV
• Previous or presnt malignancy

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

RECRUITING

MeSH Terms

Interventions

Bone Marrow Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Moshe Yeshurun, MD

  Institution of Hematology, Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Yeshurun, MD

CONTACT

0526015543; moshe.yeshurun@gmail.com

Liat Shargian, MD

CONTACT

0542394930; liatshr@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Moshe Yeshurun, Head Bone Marrow Unit

Model Details: Combined kidney and bone marrow transplantation

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: January 19, 2016
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)