NCT01459107

Human Upper Extremity Allotransplantation

Recruiting now Phase 2 Last updated 11 May 2025

What this trial tests

Phase 2 trial testing Deceased donor hand transplantation in Amputation, Traumatic in 30 participants. Currently enrolling.

Timeline

21 July 2011

Primary endpoint
30 June 2036

30 June 2036

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	21 July 2011
Primary completion	30 June 2036
Estimated completion	30 June 2036
Sites	1 location across United States

Drugs / interventions tested

• Deceased donor hand transplantation
• Bone marrow cell-based therapy & single-drug immunosuppression. — full drug profile →

Conditions studied

• Amputation, Traumatic — all drugs for Amputation, Traumatic →
• Wounds and Injuries — all drugs for Wounds and Injuries →
• Hand Injuries — all drugs for Hand Injuries →

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 69, any sex, with Amputation, Traumatic or Wounds and Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 immunosuppression.

Significance of Research: Hand transplantation could help upper extremity amputees recover functionality, self-esteem, and the capability to reintegrate into family and social life as "whole" individuals. The protocol offers the potential for minimizing the morbidity of maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this life-enhancing procedure and enabling widespread clinical application of hand transplantation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Identification and characterization of a large source of primary mesenchymal stem cells tightly adhered to bone surfaces of human vertebral body marrow cavities.
   Johnstone BH, Miller HM, Beck MR, Gu D, et al · · 2020 · cited 11× · PMID 32873509 · DOI 10.1016/j.jcyt.2020.07.003
2. Ischemia considerations for the development of an organ and tissue donor derived bone marrow bank.
   Woods EJ, Sherry AM, Woods JR, Hardin JW, et al · · 2020 · cited 6× · PMID 32758261 · DOI 10.1186/s12967-020-02470-1