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Stem Cell Therapy

Donor Stem Cell Infusion for Kidney Transplant

Phase 1 & 2
Waitlist Available
Research Sponsored by Talaris Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is receiving first renal transplant
Patient is receiving a renal transplant only
Must not have
Clinically active bacterial, fungal, viral or parasitic infection
BMI >35 or <18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month to three years
Awards & highlights

Summary

This trial is testing a new way to give kidney transplants that may allow patients to reduce or stop taking immunosuppressive drugs.

Who is the study for?
This trial is for individuals aged 18-65 who are receiving their first kidney transplant from a living donor, with no previous transplants and a negative crossmatch. Participants must not be pregnant, agree to use contraception for a year post-transplant, live within four hours of the facility for three months after the procedure, and have insurance or funding for the transplant.
What is being tested?
The study tests whether infusing enriched hematopoietic stem cells into kidney transplant recipients can establish chimerism (a state where both donor and recipient cells coexist) to reduce or stop the need for drugs that suppress the immune system.
What are the potential side effects?
Potential side effects may include reactions related to stem cell infusion, complications from graft-versus-host disease if it occurs despite measures taken in this study, and typical risks associated with immune-suppressive therapy reduction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am getting my first kidney transplant.
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I am receiving a kidney transplant only.
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I am between 18 and 65 years old and qualify for a kidney transplant due to organ failure.
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My insurance or funding will cover my transplant and any research-related issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an active infection.
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My BMI is either above 35 or below 18.
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I've had radiation therapy at a dose too high for total body irradiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month to three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month to three years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Level of Donor Chimerism from Enriched Hematopoietic Stem Cell Engraftment

Trial Design

1Treatment groups
Experimental Treatment
Group I: Living or Deceased Donor Kidney AllograftExperimental Treatment1 Intervention
Recipients with the need for a living kidney allograft are treated with an enriched hematopoetic stem cell infusion from the same living donor. Recipients with the need for a deceased donor kidney allograft are treated with an enriched hematopoetic stem cell infusion from the same deceased donor

Find a Location

Who is running the clinical trial?

Talaris Therapeutics Inc.Lead Sponsor
11 Previous Clinical Trials
64 Total Patients Enrolled
2 Trials studying Kidney Failure
37 Patients Enrolled for Kidney Failure
Northwestern UniversityOTHER
1,625 Previous Clinical Trials
937,251 Total Patients Enrolled
4 Trials studying Kidney Failure
812 Patients Enrolled for Kidney Failure
Suzanne T Ildstad, MDStudy DirectorTalaris Therapeutics Inc.
6 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Kidney Failure

Media Library

Enriched Hematopoietic Stem Cell Infusion (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00498160 — Phase 1 & 2
Kidney Failure Research Study Groups: Living or Deceased Donor Kidney Allograft
Kidney Failure Clinical Trial 2023: Enriched Hematopoietic Stem Cell Infusion Highlights & Side Effects. Trial Name: NCT00498160 — Phase 1 & 2
Enriched Hematopoietic Stem Cell Infusion (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00498160 — Phase 1 & 2
~2 spots leftby Sep 2025
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