Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)

NCT02051673 | Unknown

• 1 other identifier: ICT-7392-Compassionate Use
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)

Conditions

Renal Failure

Keywords

Kidney Transplantation

Interventions

Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion BIOLOGICAL

Enriched Hematopoetic Stem Cell Infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
• Patient is receiving first renal transplant
• Patient is receiving a renal transplant only
• The crossmatch is negative between donor and recipient
• Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of initiating total body irradiation (TBI) and agree to use reliable contraception for 1 year following transplant
• Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF)
• No evidence of donor-specific antibody presently or historically

You may not qualify if:

• Clinically active bacterial, fungal, viral or parasitic infection
• Pregnancy
• Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant
• Previous radiation therapy at a dose which would preclude TBI
• Positive crossmatch between donor and recipient
• Evidence for immunologic memory against donor
• BMI \>35 or \<18
• Re-transplant
• Positive serologies for hepatitis B virus (HBV), hepatitis C virus (HCV), HIV

Sponsors & Collaborators

• Talaris Therapeutics Inc.: lead
• Northwestern University: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Suzanne T Ildstad, MD

  Talaris Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 31, 2014
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

US (1)