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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month to three years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met