Clinical trial NCT03400345: Human Upper Extremity Allotransplantation: F/U Protocol
Official title: Human Upper Extremity Allotransplantation: Transplanted Patient Follow-Up Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amputation, Traumatic
Wounds and Injury
Hand Injuries
Keywords: Hand Transplant
composite tissue allograft (CTA)
Vascularized Composite Allotransplantation (VCA)
Amputation
Upper Limb
Immunosuppression
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women who have previously received unilateral or bilateral upper limb transplants.

Brief summary: Upper extremity allotransplantation is a new procedure which is becoming more common in the United States. Ongoing data collection for research purposes is vital to the long-term assessment as to the safety of the procedure and accompanying immunosuppression protocol, as well as quantifying patient outcomes and changes in quality of life. For these reasons, The Johns Hopkins Hand/Arm Transplantation Team is interested in enrolling transplanted patients in a follow-up protocol to continue collecting informative data to further the field of vascularized composite allotransplantation.


Eligibility criteria: Inclusion Criteria:

* Males and females 5 or more years post-unilateral or bilateral upper limb transplantation.
* Completes the protocol informed consent form.
* Consents to sample collection and storage (biopsies).
* USA citizen or equivalent.
* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.

Exclusion Criteria:

* Candidate has not received an upper extremity allotransplant.
* Any reason the study team thinks would cause the participant to be noncompliant or would put the patient at unacceptable risk if enrolled.

Primary outcomes:
measure: Quality of life (QOL) for upper extremity transplant recipients via Functional Assessment with rehabilitation using Carroll Test
timeFrame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))
measure: QOL assessed for Hand Function by Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))
measure: QOL assessed by Lawton Instrumental Activities of Daily Living (ADL/IADL) Questionnaire
timeFrame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))
measure: Michigan Hand Outcomes Questionnaire
timeFrame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
measure: Short Musculoskeletal Function Assessment (SMFA)
timeFrame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
measure: Brief Pain Inventory (Short Form) (BPISF)
timeFrame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
measure: Quality of life assessed for Psychological Measures by Brief Symptom Inventory
timeFrame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
measure: Psychological Measures by Satisfaction with Life Scale (SWLS)
timeFrame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
measure: Psychological Measures assessed by Affect Balance Scale (ABS)
timeFrame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
measure: Psychological Measures assessed by NEO Five-Factor Inventory (NEO-FFI)
timeFrame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))
Secondary outcomes:
measure: The efficacy of various immunosuppression regimens via ImmuKnow Assay/Cylex including immunomodulatory protocols (aka - Pittsburgh Protocol, Starzl Protocol), for maintenance of unilateral and bilateral upper extremity allotransplants.
timeFrame: Annually for 5 years post-enrollment (±90 days)
measure: Immunology- antibody testing by obtaining donor specific antibodies (DSA) by Luminex
timeFrame: Annually for 5 years (±90 days)
measure: Perform Skin Biopsy
timeFrame: Annually for 5 years (±90 days)
measure: Use CT Angiography
timeFrame: Annually for 5 years (±90 days)
measure: Magnetic Resonance (MR) Neurography
timeFrame: Annually for 5 years (±90 days)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jaimie Shores, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shores JT, Malek V, Lee WPA, Brandacher G. Outcomes after hand and upper extremity transplantation. J Mater Sci Mater Med. 2017 May;28(5):72. doi: 10.1007/s10856-017-5880-0. Epub 2017 Mar 30.
citation: Shores JT, Brandacher G, Lee WPA. Hand and upper extremity transplantation: an update of outcomes in the worldwide experience. Plast Reconstr Surg. 2015 Feb;135(2):351e-360e. doi: 10.1097/PRS.0000000000000892.
citation: Adler BL, Albayda J, Shores JT, Lee WPA, Brandacher G, Bingham CO 3rd. Erosive Rheumatoid Arthritis After Bilateral Hand Transplantation. Ann Intern Med. 2017 Aug 1;167(3):216-218. doi: 10.7326/L16-0588. Epub 2017 Jun 27. No abstract available.