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Hand Transplant for Hand Loss from Trauma

Phase 2

Recruiting

Led By Jaimie Shores, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Below-shoulder amputation

Aged 18-69 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up transplantation to end of study period (up to 5 years)

Awards & highlights

Study Summary

This trial will test a new immunosuppressive protocol for hand transplants that may minimize the risks associated with long-term, high-dose immunosuppression.

Who is the study for?

This trial is for adults aged 18-69 who've lost a hand, forearm, or arm and want to undergo transplantation. They must be in good health without conditions that could interfere with the treatment, willing to follow the protocol including bone marrow infusion, and able to pay for care if not a US citizen. Women of childbearing age should agree to use contraception.Check my eligibility

What is being tested?

The study tests a new approach combining bone marrow cell therapy with low-dose immunosuppression (Pittsburgh Protocol) in hand transplants from deceased donors. The goal is safer and more effective limb restoration by reducing long-term high-dose medication needs after transplanting hands/forearms.See study design

What are the potential side effects?

Potential side effects include those related to immunosuppressive drugs such as increased risk of infection, cancer development potential due to weakened immune system defenses, metabolic issues, and possible adverse reactions specific to bone marrow cell infusions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had an amputation below the shoulder.

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I am between 18 and 69 years old.

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I have lost one or both arms below the shoulder in the last 6 months or earlier and want a transplant.

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I want my non-working hand replaced with a transplanted one.

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I have been cancer-free for the last 5 years.

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I agree to receive bone marrow infusions as part of my treatment.

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I am a US citizen or can pay for my transplant and follow-up care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ transplantation to end of study period (up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~transplantation to end of study period (up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and transplantation to end of study period (up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Graft Survival

Secondary outcome measures

Documentation of immunosuppression required by transplanted participants to maintain graft.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Transplantation)Experimental Treatment2 Interventions

Hand/arm transplantation in combination with a novel donor bone marrow cell-based therapy followed by single-drug immunosuppression with potential weaning.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,645 Total Patients Enrolled

28 Trials studying Wounds and Injuries

16,310 Patients Enrolled for Wounds and Injuries

Armed Forces Institute of Regenerative MedicineFED

3 Previous Clinical Trials

62 Total Patients Enrolled

1 Trials studying Wounds and Injuries

9 Patients Enrolled for Wounds and Injuries

U.S. Army Medical Research Acquisition ActivityFED

20 Previous Clinical Trials

1,961 Total Patients Enrolled

1 Trials studying Wounds and Injuries

51 Patients Enrolled for Wounds and Injuries

Media Library

Deceased Donor Hand Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT01459107 — Phase 2

Wounds and Injuries Research Study Groups: Treatment (Transplantation)

Wounds and Injuries Clinical Trial 2023: Deceased Donor Hand Transplantation Highlights & Side Effects. Trial Name: NCT01459107 — Phase 2

Deceased Donor Hand Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT01459107 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to partake in this experiment?

"This clinical trial is seeking 30 patients who have experienced amputation due to trauma, and are within the 18 - 69 age bracket."

Answered by AI

Is recruitment for this research endeavor still available?

"Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting volunteers who meet the criteria specified by researchers. This initiative was launched on July 1st 2011 and has had a recent update on May 12th 2022; it seeks 30 people from one trial site."

Answered by AI

What hazards are associated with the application of Bone marrow cell-based therapy & single-drug immunosuppression?

"We rate the safety of bone marrow cell-based therapy and single-drug immunosuppression a 2 due to existing clinical data surrounding its security, but no evidence yet demonstrating efficacy."

Answered by AI

How many individuals have registered to take part in this research project?

"Affirmative. Information found on clinicaltrials.gov affirms that this medical study, initially posted on July 1st 2011, is currently attempting to enrol participants. Approximately 30 individuals need to be recruited from a single location."

Answered by AI

Does this trial offer opportunities for participants aged 35 and older?

"This clinical trial only considers participants that are between 18 and 69 years old. Patients younger than this have 123 trials available to them, while those who are over 65 can apply for 614 different studies."

Answered by AI

Recent research and studies

Annals of SurgeryJournal

Upper-extremity Transplantation Using a Cell-based Protocol to Minimize Immunosuppression

Schneeberger, Stefan, Vijay S. Gorantla, Gerald Brandacher, Adriana Zeevi, Anthony J. Demetris, John G. Lunz, Diana M. Metes, et al.. 2013. “Upper-extremity Transplantation Using a Cell-based Protocol to Minimize Immunosuppression”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0b013e31826d90bb.

clinicaltrials.govStudy

Human Upper Extremity Allotransplantation

2011. "Human Upper Extremity Allotransplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01459107.

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