Functional RecoveryNCT07810790
Upper Extremity Vascularized Composite Allotransplantation: A Study Evaluating Safety, Functional Outcomes, and Patient-Reported Psychosocial Outcomes
A study testing Upper Extremity Vascularized Composite Allotransplantation (VCA) in people with Functional Recovery and Upper Extremity Vascularized Composite Allotransplantation, run by Yale University at 9 sites in United States.
Trial summary
The primary objective of this study is to evaluate the 5-year (60-month) allograft survival rate of upper extremity vascularized composite allotransplantation performed under the standardized CONSORT clinical protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Recovery, Upper Extremity Vascularized Composite Allotransplantation
- What is being tested?
- Upper Extremity Vascularized Composite Allotransplantation (VCA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2027to Oct 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants:
- Competent to provide informed consent, as determined through structured clinical assessment by qualified study personnel, and able to demonstrate adequate psychosocial support, including caregiver or other support-person assistance as needed, to facilitate postoperative recovery, adherence to immunosuppressive therapy, and long-term study follow-up.
- where feasible, to support psychosocial and aesthetic integration.
- Willingness to undergo comprehensive psychosocial evaluation and ongoing monitoring by the multidisciplinary team.
- Demonstrated motivation for transplantation and understanding of the investigational nature of upper extremity VCA, including its risks, potential benefits, alternatives, and long-term commitments.
- Evidence of psychological stability and adaptive coping, with attention to prior trauma, grief, and body-image disturbances; stable treatment for conditions such as depression, anxiety, or post-traumatic stress disorder is acceptable when documented and appropriately managed.
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- Demonstrated capacity for adherence and, when available, a history of adherence to complex medical regimens, such as chronic disease treatment, dialysis, or transplant care, recognizing that prior barriers may be mitigated through structured supports and longitudinal follow-up.
- Availability of adequate family, caregiver, and/or social support, including an identified caregiver, support person, or formal support services, sufficient to assist with postoperative recovery, medication adherence, transportation, and psychosocial needs. A caregiver/family information sheet will be provided to support persons to promote realistic expectations prior to consent.
- Final psychosocial approval by a transplant mental health professional in consultation with the broader psychosocial team.
- Severe upper extremity disfigurement involving amputation proximal to the wrist.
- Conventional restorative options, including advanced myoelectric or body-powered prostheses, must be documented as exhausted (defined as a minimum of 12 months of consistent use of myoelectric or body-powered prostheses with a QuickDASH score remaining above 30), infeasible (due to stump length or soft tissue coverage), or clinically inadequate for restoring the sensory-motor integration required for the participant's essential functional needs.
- Identified plan for access to immunosuppressive medications and required follow up care (e.g., insurance coverage, assistance programs, institutional support), coordinated with social work and financial counseling.
- Willingness and ability, with available supports, to attend required follow up visits (in person or via approved telehealth where appropriate).
- Donor:
- Legal declaration of brain death
- Documented consent for VCA donation.
- ABO and HLA compatibility with the intended recipient.
- Negative crossmatch with the intended recipient (unless protocol specified exceptions are approved by immunology and the IRB).
- EBV and CMV serostatus known (CMV mismatch (donor-positive/recipient-negative (D+/R-) is not automatically exclusionary but managed by the multidisciplinary study team).
- Upper extremity anatomy suitable for transplant (no significant upper extremity trauma, major congenital anomalies, or prior upper extremity surgery that would preclude safe procurement or acceptable aesthetic/functional outcomes).
- Reasonably matched skin tone and sex, where feasible, to support psychosocial and aesthetic integration.
Who cannot join
- Anatomical or surgical factors that render transplantation unsafe or technically unfeasible (e.g., prohibitive vascular disease, prior surgeries precluding adequate anastomoses) in the judgment of the surgical team.
- Positive Human Immunodeficiency Virus (HIV) serology (unless future evidence and institutional policy support inclusion under tightly controlled conditions).
- Active or inadequately treated serious infection, including tuberculosis, hepatitis B or C with uncontrolled viremia, or syphilis.
- Active malignancy.
- History of melanoma or other high risk, virus driven malignancies.
- Malignancy in remission <5 years, except for selected low risk, non viral cancers explicitly reviewed and approved by the transplant team.
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- Must have clearance for transplant from oncology.
- Decompensated liver disease without hepatology clearance
- Decompensated or advanced cirrhosis
- Uncontrolled or uncorrectable comorbidities that substantially elevate perioperative or immunosuppressive risk despite optimization efforts (e.g., uncontrolled diabetes with end organ damage, uncontrolled hypertension, uncorrected coagulopathy).
- Current pregnancy or stated intent to become pregnant within 12 months of transplant.
- Inability or unwillingness to use effective contraception, when applicable.
- Documented pattern of poor adherence or inability to engage with follow up despite reasonable, trauma informed efforts to reduce barriers (e.g., transportation, scheduling, health literacy, financial support).
- Active psychiatric illness that currently impairs judgment, decisional capacity, or capacity to adhere to care (e.g., untreated psychosis, severe untreated depression with suicidality, impaired reality testing), as determined by the transplant psychosocial team.
- Smoking at the time of transplantation (including cigarettes, vaping, or nicotine products)
- Active substance use disorder (alcohol or drugs) without sustained remission and without adequate recovery supports, unless the multidisciplinary team determines that risk has been sufficiently mitigated.
- Persistent, unrealistic expectations about transplant outcomes that do not resolve despite structured education and counseling.
- Absence of any viable psychosocial or financial support pathway after reasonable efforts to develop one (e.g., no caregiver and no alternative formal support options, or no feasible mechanism to obtain essential medications).
- Inability to provide informed consent, even with appropriate accommodations (e.g., language services, plain language materials, decision aids), and no appropriate legally authorized representative where required.
- Any other condition or circumstance judged by the multidisciplinary transplant team and IRB to pose unacceptable risk or compromise ethical conduct of the study.
- Donor:
- Positive serology for HIV, HBV, HCV, TB, or syphilis, or other identified transmissible infections per current OPTN/UNOS and PHS guidance. HTLV testing will be conducted in line with current OPTN standards for donors with potential transmissible infections that are treatable in the recipient.
- Known history of cancer, especially head/neck or hematologic malignancy.
- Permanent upper extremity tattoos or highly identifiable markings judged incompatible with the recipient's preferences or the clinical/ethical judgment of the transplant team.
- History of extremity radiation that compromises tissue viability.
- Public Health Service (PHS) increased risk donors (e.g., recent IV drug use, incarceration) will not be automatically excluded but will require case by case risk assessment, full disclosure to the recipient, and documented multidisciplinary approval.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Johns Hopkins Medicine
Baltimore, Maryland, 21205
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40292
Yale New Haven Hospital / Yale University
New Haven, Connecticut, 06519
NYU Langone Health
New York, New York, 10016
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55902
About this study
Official title: Upper Extremity Vascularized Composite Allotransplantation: A Prospective Interventional Study Evaluating Safety, Functional Outcomes, and Patient-Reported Psychosocial Outcomes
The primary objective of this study is to evaluate the 5-year (60-month) allograft survival rate of upper extremity vascularized composite allotransplantation performed under the standardized CONSORT clinical protocol.
Read the detailed description
The study population includes adults with severe upper extremity disfigurement meeting the following criteria:
- Anatomic Severity: Loss of upper extremity proximal to the wrist (including transhumeral and shoulder-level levels when clinically appropriate)
- Refractory Status: prosthesis delivered unsatisfactory results
- Being tested
- Upper Extremity Vascularized Composite Allotransplantation (VCA)
- Keywords
- Composite tissue allotransplantation, Rehabilitation, Vascularized composite allotransplantation, Upper-extremity transplantation, Hand transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Extremity Vascularized Composite Allotransplantation (VCA)Procedure or surgery
Upper Extremity VCA, performed to treat severe facial defects. This procedure will be performed by qualified surgeons in accordance with standard institutional surgical practices.
| Study group | Role | What they receive |
|---|---|---|
| Upper Extremity Composite Allotransplantation | Experimental | Upper Extremity VCA performed under a standardized CONSORT clinical protocol. The study utilizes a longitudinal cohort design where each participant serves as their own control pre and post transplant. Receives: Procedure: Upper Extremity Vascularized Composite Allotransplantation (VCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Allograft Survival at 60 months
Allograft survival is defined as the continued presence of the transplanted upper extremity tissue with evidence of adequate vascular perfusion assessed as clinical evaluation by the surgical team. Survival is a binary categorical variable (Success/Failure). Failure is defined as total graft loss necessitating surgical removal (explantation).
Measured: Day 0 (surgery), weekly during initial hospitalization, months 1, 3, 6, 12, 18, 24, and annually thereafter through Month 60
Secondary outcomes (20)
Mean Active Range of Motion
Measured in degrees for the transplanted joint (the elbow (in some occasions), the wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints).
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Muscle strength assessed using Clinical Motor Grading (MRC Scale)
Medical Research Council (MRC) Scale is a standardized 0-to-5 manual muscle testing system used by clinicians to grade muscle strength and motor power. Motor strength was graded on a scale from M0 to M5, where M0 indicates no visible muscle contraction and M5 indicates normal muscle strength against full resistance
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean Grip Strength
Quantified in kilograms (kg) using a calibrated hand dynamometer
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean Pinch Strength
Quantified in kilograms (kg) using a calibrated pinch gauge
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Carroll Upper Extremity Function Test (UEFT)
A validated composite score of 33 tasks used to measure overall functional capability. Uses a 0 to 3 scale for individual task performance:0 points: Cannot complete any portion.1 point: Completes part of the test item.2 points: Completes the item slowly or clumsily.3 points: Completes the item fully and normally.Yields a cumulative score up to 99 for the dominant hand and 96 for the non-dominant hand
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
9-Hole Peg Test (9-HPT)
Measured in seconds to quantify manual dexterity and fine motor coordination.
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Sensory Detection Thresholds assessed using Semmes-Weinstein monofilament test
Evaluates light touch thresholds and protective sensation loss in hands, feet, or limbs. Determined by the minimum size of Semmes-Weinstein monofilament perceived by the patient.
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Tactile Acuity (2PD)
Measured by Static Two-Point Discrimination in millimeters (mm).
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean score General Health Status (PROMIS-29 v2.0)
29-item questionnaire that measures general physical, mental, and social health-related quality of life. Results are converted into T-scores where 50 is the average for the U.S. general population, with a standard deviation of 10. Higher score means worse symptoms or better ability.
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean score Health Utility (EQ-5D-5L)
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. It consists of consists of 5 dimensions each scored: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean score LIMB-QOL Resilience, Self Care and Fine Motor
Evaluates resilience, self care and fine motor following major extremity injury. Higher scores reflect a more positive outcome. Scored on a T-score metric with a mean of 50 and a standard deviation of 10.
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean score Upper Extremity Disability (QuickDASH)
An 11-item self-reported tool measuring upper extremity physical function and symptoms. Scores range from 0 (no disability) to 100 (most severe disability).
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Number of participants with Opportunistic infections
Number of participants with Opportunistic infections
Measured: Day 0 (surgery) through Month 60
Number of participants with Malignancies
Number of participants with Malignancies
Measured: Day 0 (surgery) through Month 60
Number of participants with Organ toxicity
Number of participants with Organ toxicity
Measured: Day 0 (surgery) through Month 60
Number of participants that complete all assessments
Number of participants that complete all assessments
Measured: Day 0 (surgery) through Month 60
Number of participants that complete the Central Review Agreement
Number of participants that complete the Central Review Agreement
Measured: Day 0 (surgery) through Month 60
Acute Rejection Incidence and Severity
The total number of Biopsy-Proven Acute Rejection (BPAR) episodes per patient and their severity as graded by the Banff VCA classification.
Measured: Weekly for the first month, monthly for the first year, quarterly until end of study (month 60)
Mean days to Reversibility of Acute Rejection
Measured by the Time to Clinical Resolution, defined as the number of days from the initiation of anti-rejection therapy to the return of the allograft to baseline clinical appearance and/or a follow-up biopsy showing a lower Banff grade or resolution.
Measured: Weekly for the first month, monthly for the first year, quarterly until end of study (month 60)
Number of participants with Chronic Allograft Rejection (CLAD/CAV):
Number of participants with Chronic Allograft Vasculopathy (CAV) or chronic skin changes as identified via protocol-driven histopathology.
Measured: Weekly for the first month, monthly for the first year, quarterly until end of study (month 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startOct 2027 (estimated)
- Primary completionOct 2037 (estimated)
- Study completionOct 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional RecoveryStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A total of five procedures will be performed. Given the five-procedure cap, enrollment opportunities will be limited and dependent upon donor availability, candidate eligibility, multidisciplinary review, and regulatory readiness across participating sites.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Bohdan Pomahac, MD, Principal investigator, Yale UniversityVijay Gorantla, MD, PhD, FRCS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810790
- Sponsor's protocol ID
- 2000042327
- Other IDs
- HT9425-23-3-0001
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Vascularized Composite Allotransplantation: A Prospective Interventional Study Evaluating Safety, Functional Outcomes, and Patient-Reported Psychosocial Outcomes
- ClinicalTrials.gov ID
- NCT07810790
- Acronym / sponsor ID
- 2000042327
- Keywords
- Composite tissue allotransplantation, Rehabilitation, Vascularized composite allotransplantation, Upper-extremity transplantation, Hand transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Study start
- Oct 2027 (estimated)
- Primary completion
- Oct 2037 (estimated)
- Study completion
- Oct 2037 (estimated)
- First posted
- 9 Sep 2026 (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 primary objective of this study is to evaluate the 5-year (60-month) allograft survival rate of upper extremity vascularized composite allotransplantation performed under the standardized CONSORT clinical protocol.
Detailed description
The study population includes adults with severe upper extremity disfigurement meeting the following criteria:
- Anatomic Severity: Loss of upper extremity proximal to the wrist (including transhumeral and shoulder-level levels when clinically appropriate)
- Refractory Status: prosthesis delivered unsatisfactory results
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A total of five procedures will be performed. Given the five-procedure cap, enrollment opportunities will be limited and dependent upon donor availability, candidate eligibility, multidisciplinary review, and regulatory readiness across participating sites.
| Arm | Type | Receives |
|---|---|---|
| Upper Extremity Composite Allotransplantation | Experimental | Procedure: Upper Extremity Vascularized Composite Allotransplantation (VCA)Upper Extremity VCA performed under a standardized CONSORT clinical protocol. The study utilizes a longitudinal cohort design where each participant serves as their own control pre and post transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Competent to provide informed consent, as determined through structured clinical assessment by qualified study personnel, and able to demonstrate adequate psychosocial support, including caregiver or other support-person assistance as needed, to facilitate postoperative recovery, adherence to immunosuppressive therapy, and long-term study follow-up.
- where feasible, to support psychosocial and aesthetic integration.
- Willingness to undergo comprehensive psychosocial evaluation and ongoing monitoring by the multidisciplinary team.
- Demonstrated motivation for transplantation and understanding of the investigational nature of upper extremity VCA, including its risks, potential benefits, alternatives, and long-term commitments.
- Evidence of psychological stability and adaptive coping, with attention to prior trauma, grief, and body-image disturbances; stable treatment for conditions such as depression, anxiety, or post-traumatic stress disorder is acceptable when documented and appropriately managed.
Key exclusion criteria (26 listed)
- Anatomical or surgical factors that render transplantation unsafe or technically unfeasible (e.g., prohibitive vascular disease, prior surgeries precluding adequate anastomoses) in the judgment of the surgical team.
- Positive Human Immunodeficiency Virus (HIV) serology (unless future evidence and institutional policy support inclusion under tightly controlled conditions).
- Active or inadequately treated serious infection, including tuberculosis, hepatitis B or C with uncontrolled viremia, or syphilis.
- Active malignancy.
- History of melanoma or other high risk, virus driven malignancies.
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 |
|---|---|---|
| Upper Extremity Vascularized Composite Allotransplantation (VCA)Upper Extremity VCA, performed to treat severe facial defects. This procedure will be performed by qualified surgeons in accordance with standard institutional surgical practices. | Procedure or surgery | Upper Extremity Composite Allotransplantation |
Primary outcome
Number of participants with Allograft Survival at 60 months
Time frame: Day 0 (surgery), weekly during initial hospitalization, months 1, 3, 6, 12, 18, 24, and annually thereafter through Month 60
Allograft survival is defined as the continued presence of the transplanted upper extremity tissue with evidence of adequate vascular perfusion assessed as clinical evaluation by the surgical team. Survival is a binary categorical variable (Success/Failure). Failure is defined as total graft loss necessitating surgical removal (explantation).
20 secondary outcomes
Mean Active Range of Motion
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Muscle strength assessed using Clinical Motor Grading (MRC Scale)
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean Grip Strength
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean Pinch Strength
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Carroll Upper Extremity Function Test (UEFT)
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
9-Hole Peg Test (9-HPT)
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Sensory Detection Thresholds assessed using Semmes-Weinstein monofilament test
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Tactile Acuity (2PD)
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean score General Health Status (PROMIS-29 v2.0)
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean score Health Utility (EQ-5D-5L)
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean score LIMB-QOL Resilience, Self Care and Fine Motor
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Mean score Upper Extremity Disability (QuickDASH)
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Number of participants with Opportunistic infections
Time frame: Day 0 (surgery) through Month 60
Number of participants with Malignancies
Time frame: Day 0 (surgery) through Month 60
Number of participants with Organ toxicity
Time frame: Day 0 (surgery) through Month 60
Number of participants that complete all assessments
Time frame: Day 0 (surgery) through Month 60
Number of participants that complete the Central Review Agreement
Time frame: Day 0 (surgery) through Month 60
Acute Rejection Incidence and Severity
Time frame: Weekly for the first month, monthly for the first year, quarterly until end of study (month 60)
Mean days to Reversibility of Acute Rejection
Time frame: Weekly for the first month, monthly for the first year, quarterly until end of study (month 60)
Number of participants with Chronic Allograft Rejection (CLAD/CAV):
Time frame: Weekly for the first month, monthly for the first year, quarterly until end of study (month 60)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- 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.
Bohdan Pomahac, MD principal investigator
Yale University
Vijay Gorantla, MD, PhD, FRCS principal investigator
Wake Forest University Health Sciences
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Extremity Vascularized Composite Allotransplantation (VCA) in people with Functional Recovery and Upper Extremity Vascularized Composite Allotransplantation, run by Yale University at 9 sites 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 21 inclusion and 26 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: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omowunmi Afolabi, MSc. Psychology (203-737-4752, omowunmi.afolabi@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Allograft Survival at 60 months (time frame: Day 0 (surgery), weekly during initial hospitalization, months 1, 3, 6, 12, 18, 24, and annually thereafter through Month 60). 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 15 Sep 2026.