NCT00722280

Brief Summary

Overall Goal To establish hand transplantation as a safe and effective reconstructive strategy for the treatment of upper extremity amputations. Specific Aim To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long term high dose immunosuppression. For this purpose, we propose to utilize the "Pittsburgh Protocol", which is an immunomodulatory strategy that has been implemented in solid organ transplants at UPMC. Early results in living related liver and kidney patients have confirmed that this protocol provides the means to allow graft survival with minimization of maintenance immunosuppression and even allows weaning of some patients from long-term immunosuppression.We hypothesize that a similar protocol can enable graft survival in highly immunogenic composite tissue allografts like hand transplants while reducing the number,dosing and/or frequency of immunosuppressive drugs associated with serious adverse effects.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

8.8 years

First QC Date

July 23, 2008

Last Update Submit

October 15, 2018

Conditions

Amputation, Traumatic

Keywords

Amputation, upper limb, composite tissue, immunosuppression

Outcome Measures

Primary Outcomes (1)

  • Graft survival

    One to ten years

Secondary Outcomes (1)

  • Functional Outcome

    One to ten years

Study Arms (1)

Hand Transplantation

EXPERIMENTAL

Described above

Procedure: Hand Transplantation

Interventions

Hand TransplantationPROCEDURE

This program is the primary site for a novel immune modulation protocol for hand and/or forearm transplantation using donor bone marrow stem cells. This protocol, otherwise called the "Pittsburgh Protocol" has been published and implemented in 8 hand/forearm transplantations. The Pittsburgh hand transplant program is the only center that has experience with the "Pittsburgh Protocol" to reduce the number and dosing of immunosuppressive drugs used to prevent rejection of hand/forearm transplants.

Also known as: Induction Immunosuppression, Maintenance Immunosuppression, Surgical Transplantation of Human Hand or Forearm, Rehabilitation
Hand Transplantation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age (\>18 years \<60 years): Recipients \<18 years of age are excluded due to limitations of giving full informed consent and the potentially increased risk of lymphoproliferative disorder in a younger population. Once hand transplantation and in particular the strategy for minimizing immunosuppression has proven to be efficacious and safe, the restrictions with regard to recipient age may be relaxed.
  • No serious co-existing medical (coronary artery disease, diabetes) or psycho-social problems (including alcoholism, drug abuse).
  • Must be negative for malignancy (for 10 years) or HIV (at transplant).
  • Negative crossmatch with donor.
  • Negative pregnancy test in female recipient of child bearing potential and consent to use reliable contraception for at least one year following transplantation.
  • Consent to cell collection, storage, and bone marrow infusion as part of the treatment regime.
  • Amputation may be recent (acute injury) or remote (patient may have undergone rehabilitation with prostheses).

You may not qualify if:

  • Conditions that may impact the immunomodulatory protocol: These include diseases like HIV or malignancy that could expose the recipient to an unacceptable risk under immunosuppressive treatment. Sensitized recipients with high level of preformed antibodies are also at risk.
  • Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications: These include inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thallassemias, Sickle Cell disease etc. Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (8)

  • Gorantla VS, Brandacher G, Schneeberger S, Zheng XX, Donnenberg AD, Losee JE, Lee WP. Favoring the risk-benefit balance for upper extremity transplantation--the Pittsburgh Protocol. Hand Clin. 2011 Nov;27(4):511-20, ix-x. doi: 10.1016/j.hcl.2011.08.008.

    PMID: 22051391BACKGROUND

  • Ravindra KV, Gorantla VS. Development of an upper extremity transplant program. Hand Clin. 2011 Nov;27(4):531-8, x. doi: 10.1016/j.hcl.2011.07.008. Epub 2011 Oct 6.

    PMID: 22051393BACKGROUND

  • Lovasik D, Foust DE, Losee JE, Lee WP, Brandacher G, Gorantla VS. Helping hands: caring for the upper extremity transplant patient. Crit Care Nurs Clin North Am. 2011 Sep;23(3):505-17. doi: 10.1016/j.ccell.2011.09.002.

    PMID: 22054824BACKGROUND

  • Breidenbach WC, Meister EA, Becker GW, Turker T, Gorantla VS, Hassan K, Kaplan B. A Statistical Comparative Assessment of Face and Hand Transplantation Outcomes to Determine Whether Either Meets the Standard of Care Threshold. Plast Reconstr Surg. 2016 Jan;137(1):214e-222e. doi: 10.1097/PRS.0000000000001893.

    PMID: 26710054BACKGROUND

  • Breidenbach WC, Meister EA, Turker T, Becker GW, Gorantla VS, Levin LS. A Methodology for Determining Standard of Care Status for a New Surgical Procedure: Hand Transplantation. Plast Reconstr Surg. 2016 Jan;137(1):367-373. doi: 10.1097/PRS.0000000000001892.

    PMID: 26710038BACKGROUND

  • Gorantla VS, Schneeberger S, Moore LR, Donnenberg VS, Zimmerlin L, Lee WP, Donnenberg AD. Development and validation of a procedure to isolate viable bone marrow cells from the vertebrae of cadaveric organ donors for composite organ grafting. Cytotherapy. 2012 Jan;14(1):104-13. doi: 10.3109/14653249.2011.605350. Epub 2011 Sep 12.

    PMID: 21905958RESULT

  • Lang RS, Gorantla VS, Esper S, Montoya M, Losee JE, Hilmi IA, Sakai T, Lee WP, Raval JS, Kiss JE, Shores JT, Brandacher G, Planinsic RM. Anesthetic management in upper extremity transplantation: the Pittsburgh experience. Anesth Analg. 2012 Sep;115(3):678-88. doi: 10.1213/ANE.0b013e31825da401. Epub 2012 Jun 28.

    PMID: 22745115RESULT

  • Schneeberger S, Gorantla VS, Brandacher G, Zeevi A, Demetris AJ, Lunz JG, Metes DM, Donnenberg AD, Shores JT, Dimartini AF, Kiss JE, Imbriglia JE, Azari K, Goitz RJ, Manders EK, Nguyen VT, Cooney DS, Wachtman GS, Keith JD, Fletcher DR, Macedo C, Planinsic R, Losee JE, Shapiro R, Starzl TE, Lee WP. Upper-extremity transplantation using a cell-based protocol to minimize immunosuppression. Ann Surg. 2013 Feb;257(2):345-51. doi: 10.1097/SLA.0b013e31826d90bb.

    PMID: 23001085RESULT

MeSH Terms

Conditions

Amputation, Traumatic

Interventions

Hand TransplantationRehabilitation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Vascularized Composite AllotransplantationOrgan TransplantationTransplantationSurgical Procedures, OperativeTransplantation, HomologousAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Joseph E Losee, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

  • Vijay S Gorantla, MD, PhD

    University of Pittsburgh Medical Center

    STUDY DIRECTOR

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
Assistant Professor

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

December 1, 2008

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)