Heart TransplantationPhase 2NCT00151164
Thymic Tolerance in Pediatric Heart Transplantation
A Phase 2 study testing donor bone marrow cell injection into thymus gland in people with Heart Transplantation, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
The investigators hypothesize that injecting donor bone marrow cells into the recipient thymus gland at the time of heart transplantation in children will prove to be feasible and safe. Read more about this study
- Who is it for?
- Ages 1 day to 20 years
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- donor bone marrow cell injection into thymus gland
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Oct 2007
- Phase
- Phase 2
- 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 1 day to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Less than 21 years of age at listing
- Listed for primary orthotopic heart transplant at Children's Hospital of Pittsburgh, between 04/01/04 and 03/31/08
Who cannot join
- History of prior transplant
- Listed for multi-organ transplant
- Sensitized against human HLA tissue types
- Documentation of total thymomectomy during a prior surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The investigators hypothesize that injecting donor bone marrow cells into the recipient thymus gland at the time of heart transplantation in children will prove to be feasible and safe. They further hypothesize that recipients receiving donor bone marrow will experience less acute rejection events with reduced long-term requirements for immunosuppressive medications when compared to controls who do not receive marrow but who are managed under an identical immunosuppressive protocol.
- Conditions
- Heart Transplantation
- Being tested
- donor bone marrow cell injection into thymus gland
- Keywords
- transplantation tolerance, thymus, bone marrow, pediatric heart transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donor bone marrow cell injection into thymus glandProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if intra-thymic inoculation of donor bone marrow cells at time of heart transplantation in children will reduce frequency of acute rejection as well as long-term requirements of immunosuppressive medications when compared to control patients
Secondary outcomes (1)
Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: Due to failure to control sufficient patients in the active arm, this study has now been closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Pittsburgh
- Investigators
- Steven A. Webber, MBChB, Principal investigator, University of Pittsburgh Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151164
- Sponsor's protocol ID
- 551
- Other IDs
- P50HL074732-04, 0404019
- Status last verified
- Jan 2008
- First submitted
- 6 Sep 2005
- Last updated
- 12 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thymic Tolerance in Pediatric Heart Transplantation
- ClinicalTrials.gov ID
- NCT00151164
- Acronym / sponsor ID
- 551
- Conditions
- Heart Transplantation
- Keywords
- transplantation tolerance, thymus, bone marrow, pediatric heart transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to failure to control sufficient patients in the active arm, this study has now been closed.
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- University of Pittsburgh
- Study start
- Apr 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 8 Sep 2005 (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.
The investigators hypothesize that injecting donor bone marrow cells into the recipient thymus gland at the time of heart transplantation in children will prove to be feasible and safe. They further hypothesize that recipients receiving donor bone marrow will experience less acute rejection events with reduced long-term requirements for immunosuppressive medications when compared to controls who do not receive marrow but who are managed under an identical immunosuppressive protocol.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 day to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Less than 21 years of age at listing
- Listed for primary orthotopic heart transplant at Children's Hospital of Pittsburgh, between 04/01/04 and 03/31/08
Key exclusion criteria (4 listed)
- History of prior transplant
- Listed for multi-organ transplant
- Sensitized against human HLA tissue types
- Documentation of total thymomectomy during a prior surgery
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 |
|---|---|---|
| donor bone marrow cell injection into thymus gland | Procedure or surgery | – |
Primary outcome
Determine if intra-thymic inoculation of donor bone marrow cells at time of heart transplantation in children will reduce frequency of acute rejection as well as long-term requirements of immunosuppressive medications when compared to control patients
1 secondary outcome
Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls
Results and safety
The study was stopped early (reason given: Due to failure to control sufficient patients in the active arm, this study has now been closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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.
Steven A. Webber, MBChB principal investigator
University of Pittsburgh Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing donor bone marrow cell injection into thymus gland in people with Heart Transplantation, run by National Heart, Lung, and Blood Institute (NHLBI) 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Jul 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to failure to control sufficient patients in the active arm, this study has now been closed.). 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.
What does the primary outcome measure?
Determine if intra-thymic inoculation of donor bone marrow cells at time of heart transplantation in children will reduce frequency of acute rejection as well as long-term requirements of immunosuppressive medications when compared to control patients. It is what the study was designed to measure, not a finding.
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 12 Jul 2016.