Amputation, TraumaticEarly Phase 1NCT03241719
Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA
A Early Phase 1 study testing IL-2 in people with Amputation, Traumatic and Amputation;Traumatic;Old, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objective of this study is to develop a feasible and safe regimen for minimization of immune suppression in recipients of vascularized composite allotransplants (VCA) using a daily dose of recombinant IL-2. In order to achieve this aim, this trial will: 1. Perform VCA in 5 eligible subjects; 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amputation, Traumatic, Amputation;Traumatic;Old, Face Injury
- What is being tested?
- IL-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2017to 21 Jul 2021
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the VCA portion of the study:
- Patients referred due to one or more of these conditions: (1) severe facial deformity comprising more than 25% of the facial area and/or one or more of the central facial units (i.e. lip(s), nose, eye(s)), (2) single or bilateral upper limb(s) amputation, where at least one of the limbs was amputated at the level of the wrist or more proximal, up to the functional shoulder joint, and (3) severe abdominal wall defect comprising more than 50% of the functional abdominal wall.
- Injuries must have taken place no more than 15 years and no less than 6 months prior to presentation for consideration.
- All other conventional reconstruction approaches will have been either exhausted, or ruled out due to poor prognosis of outcomes.
- Patients will need to possess strong motivation and a willingness to commit to post-transplant rehabilitation.
- Normal renal and hepatic function within acceptable medical parameters
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- For the recombinant IL-2 phase of the study:
- At least 3 months have elapsed since the VCA transplant operation
- At least 4 weeks on stable immune suppression and steriods (<5 mg QD).
- No addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range for that drug.
- Medical evaluations, clinical and laboratory assessments must deem that participants have adequate organ function.
- The effects of some of the study drugs on the developing human fetus are unknown, or toxic. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence prior to study entry and for the duration of study participation). Should a women become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Subjects must be able to understand and willing to sign a written informed consent document.
- Skin biopsies from the transplanted parts must show no evidence of rejection for at least 3 months prior to study enrollment.
Who cannot join
- For the VCA portion of the study:
- History of poor compliance with prostheses or rehabilitation
- Impaired renal, cardiac and/or pulmonary function
- Compromised ability to understand the risk and benefits of participation in the study
- Active malignancy
- Single non-dominant upper limb amputation and no other vascularized composite tissue injuries justifying VCA
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- For the IL-2 portion of the study:
- Active infection
- Non-healing wounds
- Pregnancy, because of the potential for teratoenic or abortifacient effects. There is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother, therefore breastfeeding should be discontinued.
- Rejection episodes within the past 3 months
- Concurrent use of calcineurin-inhibitor plus sirolimus
- New immunosuppressive medication in the 4 weeks prior
- Post-transplant exposure to T-cell or IL-2 targeted medication (e.g. ATG, alemtuzumab, basiliximab, denileukin diftitox) within 100 days prior.
- Active malignant relapse
- Donor lymphocyte infusion within 100 days prior
- Inability to comply with IL-2 treatment regime
- HIV-positive individuals because of the potential for lethal infections.
- Other investigational drugs within 4 weeks prior to enrollment, unless cleared by the principal investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in Vascularized Composite Allotransplantation
The objective of this study is to develop a feasible and safe regimen for minimization of immune suppression in recipients of vascularized composite allotransplants (VCA) using a daily dose of recombinant IL-2. In order to achieve this aim, this trial will:
- Perform VCA in 5 eligible subjects;
- Administer recombinant IL-2 at a low-dose to promote the expansion and function of regulatory T cells in subjects who received VCA; and
- Minimize immune suppression to tacrolimus single therapy in subjects who received VCA and recombinant IL-2.
Read more
This trial will also investigate if it is possible to predict immune rejection in VCA using blood and tissue samples from recipients of VCA.
Lastly, this trial will develop non-invasive technologies to monitor for VCA rejection. These technologies will involve magnetic resonance imaging. Multi-contrast ultra-high resolution MR imaging (MRI) with serial direct planimetry will be performed in recipients of VCA.
- Conditions
- Amputation, Traumatic, Amputation;Traumatic;Old, Face Injury, Face; Deformity, Abdominal Wall Defect
- Being tested
- IL-2
- Medical subject headings
- Amputation, Traumatic, Facial Injuries, Facies, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-2Drug
Subjects will receive vascularized composite allotransplantation (e.g. facial, hand and/or abdominal wall transplants) under conventional immune suppression. No sooner than 3 months after VCA, subjects will receive a protocol of daily recombinant IL-2 at low doses for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects who receive transplantation and undergo IL-2 treatment Receives: Drug: IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of regulatory T cells
Measured: 4-24 months
Secondary outcomes (4)
Number of episodes of rejection
Measured: 1-24 months
T-cell alloreactivity measured by ELISPOT
Measured: 4-24 months
Steroid dose
Measured: 6-24 months
Mycophenolate dose
Measured: 8-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start17 Oct 2017
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Why it stopped: No participants are currently receiving therapy under this protocol, funding is coming to an end and the PI is leaving the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation, TraumaticStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bodhan Pomahac, Brigham and Women's Hospital
- Investigators
- Bohdan Pomahac, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241719
- Sponsor's protocol ID
- 2017P000590
- Status last verified
- Jul 2021
- First submitted
- 1 Aug 2017
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in Vascularized Composite Allotransplantation
- ClinicalTrials.gov ID
- NCT03241719
- Acronym / sponsor ID
- 2017P000590
- Conditions
- Amputation, Traumatic, Amputation;Traumatic;Old, Face Injury, Face; Deformity, Abdominal Wall Defect
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No participants are currently receiving therapy under this protocol, funding is coming to an end and the PI is leaving the institution.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 7 Aug 2017 (actual)
- 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 objective of this study is to develop a feasible and safe regimen for minimization of immune suppression in recipients of vascularized composite allotransplants (VCA) using a daily dose of recombinant IL-2. In order to achieve this aim, this trial will:
- Perform VCA in 5 eligible subjects;
- Administer recombinant IL-2 at a low-dose to promote the expansion and function of regulatory T cells in subjects who received VCA; and
- Minimize immune suppression to tacrolimus single therapy in subjects who received VCA and recombinant IL-2.
This trial will also investigate if it is possible to predict immune rejection in VCA using blood and tissue samples from recipients of VCA.
Lastly, this trial will develop non-invasive technologies to monitor for VCA rejection. These technologies will involve magnetic resonance imaging. Multi-contrast ultra-high resolution MR imaging (MRI) with serial direct planimetry will be performed in recipients of VCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: IL-2Subjects who receive transplantation and undergo IL-2 treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients referred due to one or more of these conditions: (1) severe facial deformity comprising more than 25% of the facial area and/or one or more of the central facial units (i.e. lip(s), nose, eye(s)), (2) single or bilateral upper limb(s) amputation, where at least one of the limbs was amputated at the level of the wrist or more proximal, up to the functional shoulder joint, and (3) severe abdominal wall defect comprising more than 50% of the functional abdominal wall.
- Injuries must have taken place no more than 15 years and no less than 6 months prior to presentation for consideration.
- All other conventional reconstruction approaches will have been either exhausted, or ruled out due to poor prognosis of outcomes.
- Patients will need to possess strong motivation and a willingness to commit to post-transplant rehabilitation.
- Normal renal and hepatic function within acceptable medical parameters
Key exclusion criteria (19 listed)
- History of poor compliance with prostheses or rehabilitation
- Impaired renal, cardiac and/or pulmonary function
- Compromised ability to understand the risk and benefits of participation in the study
- Active malignancy
- Single non-dominant upper limb amputation and no other vascularized composite tissue injuries justifying VCA
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 |
|---|---|---|
| IL-2Subjects will receive vascularized composite allotransplantation (e.g. facial, hand and/or abdominal wall transplants) under conventional immune suppression. No sooner than 3 months after VCA, subjects will receive a protocol of daily recombinant IL-2 at low doses for 8 weeks. | Drug | Treatment |
Primary outcome
Number of regulatory T cells
Time frame: 4-24 months
4 secondary outcomes
Number of episodes of rejection
Time frame: 1-24 months
T-cell alloreactivity measured by ELISPOT
Time frame: 4-24 months
Steroid dose
Time frame: 6-24 months
Mycophenolate dose
Time frame: 8-24 months
Results and safety
The study was stopped early (reason given: No participants are currently receiving therapy under this protocol, funding is coming to an end and the PI is leaving the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Bohdan Pomahac, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IL-2 in people with Amputation, Traumatic and Amputation;Traumatic;Old, run by Brigham and Women's Hospital 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 14 inclusion and 19 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 28 Jul 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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: No participants are currently receiving therapy under this protocol, funding is coming to an end and the PI is leaving the institution.). 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?
Number of regulatory T cells (time frame: 4-24 months). 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 28 Jul 2021.