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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month to three years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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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
1,585 Previous Clinical Trials
917,193 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts underway for this investigation?

"According to the information hosted on clinicaltrials.gov, this particular medical study is not currently enlisting new patients for participation. This trial was first published in January of 2005 and last edited in July 2022; however, there are 177 alternate trials presently seeking candidates."

Answered by AI

What criteria must be met to qualify for participation in this experiment?

"This medical investigation is searching for 38 volunteers with end-organ kidney failure aged between 18 and 65. Eligibility requirements include the ability to stay within a four hour radius of the clinical site during the first three months after transplant, having negative crossmatching results in terms of donor-recipient compatibility, proof of coverage that can fund any research complications or associated costs, as well as a confirmed absence of pregnancy 48 hours before total body irradiation commences; furthermore, women who are capable of reproduction must also be willing to use reliable contraception for one year post-transplantation."

Answered by AI

Does this research protocol include individuals below the age of 35?

"According to the study's enrollment criteria, only individuals between 18 and 65 years old can be considered eligible participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Induction of Donor Specific Tolerance in Recipients of Live Donor Kidney Allografts by Donor Stem Cell Infusion
2005. "Induction of Donor Specific Tolerance in Recipients of Live Donor Kidney Allografts by Donor Stem Cell Infusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00498160.
~0 spots leftby Aug 2024
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