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NCT01459107 · ClinicalTrials.gov registry record · Phase 2
Human Upper Extremity Allotransplantation
A Phase 2 study of Wounds and Injuries and Amputation, Traumatic, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01459107 is a Phase 2 study of Wounds and Injuries and Amputation, Traumatic that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 30 participants, below the 503-participant average among 27 other Wounds and Injuries trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01459107, a Phase 2 study of Wounds and Injuries and Amputation, Traumatic, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Millions of people each year sustain injuries, have tumors surgically removed, or are born with defects that require complex reconstructive surgeries to repair. In the case of hand, forearm, or arm amputation, prostheses only provide less than optimal motor function and no sensory feedback. However, hand and arm transplantation is a means to restore the appearance, anatomy, and function of a native hand. Although over 70 hand transplants have been performed to date and good functional results have been achieved, widespread clinical use has been limited due to adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential benefits of hand transplantation. Study Design: This non-randomized, Phase II clinical trial will document the use of a new immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing hand transplantation as a safe and effective reconstructive treatment for upper extremity amputations by minimizing maintenance immunosuppression therapy in unilateral and bilateral hand/forearm transplant patients. This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled graft survival using low doses of a single immunosuppressive drug followed by weaning of treatment. Initially designed for living-related solid organ donation, this regimen has been adapted for use with grafts donated by deceased donors. The investigators propose to perform 30 human hand transplants employing this novel protocol. Specific Aims: 1) To establish hand transplantation as a safe and effective reconstructive strategy for the treatment of upper extremity amputations; 2) To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long-term high dose multi-drug immunosup
Conditions Studied
Interventions
- PROCEDURE Deceased donor hand transplantation
- DRUG Bone marrow cell-based therapy & single-drug immunosuppression.
Study Locations (1)
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-07-21 |
| Est. Completion | 2036-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01459107
The ClinicalTrials.gov registry entry for NCT01459107 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 503-participant average among 27 other Wounds and Injuries trials with a reported enrollment target (94% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Wounds and Injuries appearing as the primary indexed condition, and to 2 interventions - of which Deceased donor hand transplantation is the first listed.
NCT01459107 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01459107 about?
NCT01459107 is a clinical study titled "Human Upper Extremity Allotransplantation". Background: Millions of people each year sustain injuries, have tumors surgically removed, or are born with defects that require complex reconstructive surgeries to repair. In the case of hand, forearm, or arm amputation, prostheses only provide less than optimal motor function and no sensory feedba...
What is the current status of trial NCT01459107?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-07-21. Estimated completion is 2036-06-30.
What conditions does trial NCT01459107 study?
This clinical trial studies the following conditions: Wounds and Injuries, Amputation, Traumatic, Hand Injuries.
What interventions are being tested in trial NCT01459107?
The interventions under investigation include: Deceased donor hand transplantation (PROCEDURE), Bone marrow cell-based therapy & single-drug immunosuppression. (DRUG).
Who is sponsoring clinical trial NCT01459107?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01459107 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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