Clinical Trials Logo
  1. Home
  2. Renal Failure
  3. NCT02051673
  4. Details
NCT02051673 Clinical Trial

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

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02051673
Other study ID # ICT-7392-Compassionate Use
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date July 2022
Source Talaris Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

Description:

Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx) and living donor kidney transplant.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion
Enriched Hematopoetic Stem Cell Infusion

Locations
Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Talaris Therapeutics Inc. Northwestern University

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT02763410 - Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT03292029 - Pilot Medical Evaluation of the T50 Test N/A
Suspended NCT04589065 - SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device) N/A
Completed NCT03806998 - Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure Phase 3
Active, not recruiting NCT03672110 - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Phase 3
Completed NCT02325726 - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery. N/A
Completed NCT02116270 - Accelerated Immunosenescence and Chronic Kidney Disease N/A
Completed NCT01859273 - Adherence Enhancement for Renal Transplant Patients N/A
Completed NCT01388270 - Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis Phase 4
Completed NCT00966615 - The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition Phase 4
Completed NCT01187953 - Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx Phase 3
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01008631 - The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers N/A
Completed NCT00765661 - Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients Phase 2
Completed NCT00737672 - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis Phase 3
Completed NCT00808691 - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit N/A
Recruiting NCT00470769 - The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR N/A
Terminated NCT00338455 - Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC Phase 2