Renal FailureNCT02051673
Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
A study testing Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion in people with Renal Failure, run by Talaris Therapeutics Inc. at 1 site in United States.
Trial summary
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- BMI >35 or <18
- Re-transplant
- Positive serologies for hepatitis B virus (HBV), hepatitis C virus (HCV), HIV
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)
Read the detailed description
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx) and living donor kidney transplant.
- Conditions
- Renal Failure
- Being tested
- Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion
- Keywords
- Kidney Transplantation
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological/Vaccine: Enriched Hematopoetic Stem Cell InfusionBiological
Enriched Hematopoetic Stem Cell Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Talaris Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- Suzanne T Ildstad, MD, Study director, Talaris Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051673
- Sponsor's protocol ID
- ICT-7392-Compassionate Use
- Status last verified
- Jul 2022
- First submitted
- 29 Jan 2014
- Last updated
- 18 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
- ClinicalTrials.gov ID
- NCT02051673
- Acronym / sponsor ID
- ICT-7392-Compassionate Use
- Conditions
- Renal Failure
- Keywords
- Kidney Transplantation
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Talaris Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)
Detailed description
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx) and living donor kidney transplant.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological/Vaccine: Enriched Hematopoetic Stem Cell InfusionEnriched Hematopoetic Stem Cell Infusion | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne T Ildstad, MD study director
Talaris Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion in people with Renal Failure, run by Talaris Therapeutics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.