Vascularized Composite Allotransplantation for Multiple Extremity Amputations

NCT01293214 | Recruiting

• 1 other identifier: 2012P000073
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Limb transplantation surgery is the transfer of one or more limbs from a deceased human donor to a patient with single or multiple limb amputation. Hand transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of hand amputees. The purpose of this study is to develop the best practices for multiple limb transplantation that will improve the outcomes of future limb transplant recipients.

Conditions

Limb Amputation; Extremity Amputation

Keywords

limb transplantation; limb allotransplantation; hand transplantation; hand allotransplantation; hand amputation; leg transplantation

Outcome Measures

Primary Outcomes (1)

• Outcomes of limb transplantation

  We will undertake an objective evaluation of the results of limb transplantation in an "outcome-oriented" study

  Subjects will be followed for 18 months after transplantation

Secondary Outcomes (1)

• Efficacy and optimization of the immune suppression protocol

  18 months

Study Arms (1)

Transplantation

EXPERIMENTAL

Subjects will undergo single or multiple limb transplantation

Procedure: Limb transplantation

Interventions

Limb transplantation PROCEDURE

Also known as: vascularized composite allotransplantation

Transplantation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years.
• Single dominant hand or multiple limb amputation.
• Time elapsed since amputation more than 6 months but less than 15 years.
• Patient has tried prosthesis without success.
• Level of amputation anywhere from the wrist (or ankle) joint to just below the shoulder (or hip) joint, which should be functional.
• Signed written informed consent.
• Willing to complete psychological and social evaluations.
• Willing to take immunosuppressants - drugs that help prevent rejection of the transplant - for life.
• Willing to comply with extensive post-transplant rehabilitation for a minimum of two years.
• Willing to return for follow-up visits as determined by the treating physician.
• Willing to receive standard vaccinations prior to the transplant, such as influenza and hepatitis B.

You may not qualify if:

• Single, non-dominant hand amputees.
• Active malignancy.
• High risk of return of malignancy.
• History of persistent non-compliance.
• Findings of psychological evaluation that indicate inability to comply with physician's orders or mental instability.
• Any diagnosis that puts the subject at risk from limb transplant surgery or life-long immune suppression.
• Inability to ensure adequate follow-up of post-transplant care and immune suppression.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (5)

• Pomahac B, Aflaki P. Composite tissue transplantation: a new era in transplantation surgery. Eplasty. 2010 Sep 15;10:e58.

  PMID: 20862294 BACKGROUND

• Bueno E, Benjamin MJ, Sisk G, Sampson CE, Carty M, Pribaz JJ, Pomahac B, Talbot SG. Rehabilitation following hand transplantation. Hand (N Y). 2014 Mar;9(1):9-15. doi: 10.1007/s11552-013-9568-8.

  PMID: 24570631 BACKGROUND

• George E, Mitsouras D, Kumamaru KK, Shah N, Smith SE, Schultz K, Deaver PM, Mullen KM, Steigner ML, Gravereaux EC, Demehri S, Bueno EM, Talbot SG, Pomahac B, Rybicki FJ. Upper extremity composite tissue allotransplantation imaging. Eplasty. 2013 Jul 16;13:e38. eCollection 2013.

  PMID: 23943677 BACKGROUND

• Carty MJ, Zuker R, Cavadas P, Pribaz JJ, Talbot SG, Pomahac B. The case for lower extremity allotransplantation. Plast Reconstr Surg. 2013 Jun;131(6):1272-1277. doi: 10.1097/PRS.0b013e31828bd1a5.

  PMID: 23416434 BACKGROUND

• Borges TJ, Abarzua P, Gassen RB, Kollar B, Lima-Filho M, Aoyama BT, Gluhova D, Clark RA, Islam SA, Pomahac B, Murphy GF, Lian CG, Talbot SG, Riella LV. T cell-attracting CCL18 chemokine is a dominant rejection signal during limb transplantation. Cell Rep Med. 2022 Mar 15;3(3):100559. doi: 10.1016/j.xcrm.2022.100559. eCollection 2022 Mar 15.

  PMID: 35492875 DERIVED

Related Links

• Study's official webpage

MeSH Terms

Interventions

Vascularized Composite Allotransplantation

Intervention Hierarchy (Ancestors)

Organ Transplantation; Transplantation; Surgical Procedures, Operative; Transplantation, Homologous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Upper Extremity Transplant Program

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: February 1, 2010
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2025

Record last verified: 2024-08

Locations

US (1)