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Hand Transplantation for Amputation
N/A
Recruiting
Led By Sheel Sharma, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women who are of childbearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of transplant and agree to use reliable contraception for one year following transplant
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Study Summary
This trial will test if an investigational surgery that transfers tissue from a non-living donor to living individual will help restore function, appearance, and sensation to the hand and forearm areas of individuals who have suffered traumatic injury to the hand and forearm.
Who is the study for?
This trial is for men and women aged 18-60 who have lost all or part of one or both hands and forearms. They must not have had cancer in the last 5 years, be HIV negative, and not pregnant. Participants should also be willing to use contraception for a year post-transplant, have no severe diseases or psychiatric conditions that could interfere with the transplant's success, and should not have an unstable social situation.Check my eligibility
What is being tested?
The study is testing hand transplantation from deceased donors to see if it can improve function, appearance, and sensation in patients' hands and forearms after traumatic injury. Recovery will be monitored through exams, x-rays, blood tests, tissue tests, and other evaluations during follow-up visits.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include risks associated with surgery such as infection risk increase due to immunosuppressive drugs needed to prevent rejection of the transplanted hand(s), possible complications from anesthesia during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and agree to use birth control for a year after my transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number and proportion of subjects with biopsy-proven rejection
Secondary outcome measures
Number and proportion losing their VCA graft
Trial Design
1Treatment groups
Experimental Treatment
Group I: traumatic amputation of the handExperimental Treatment1 Intervention
may be male or female patients between the ages of 18 and 60 who are missing all or part of one or both hands and forearms
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,535 Total Patients Enrolled
Sheel Sharma, MDPrincipal InvestigatorNYU Langone Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have some upper arm muscles left to control a prosthetic hand.I have a birth defect that could affect my surgery results.I am not satisfied with or cannot use a prosthetic hand.I have cognitive issues that affect my daily activities.I am blind and understand that hand surgery may not fully restore my hand's sensation.I am between 18 and 60 years old and missing part or all of one or both hands and forearms.I am not pregnant and agree to use birth control for a year after my transplant.I do not have any severe infections or diseases that would prevent me from undergoing a transplant.I have tried using a prosthetic if my amputation was less than 6 months ago, unless it's not possible due to surgery needs.I have cognitive issues due to a brain injury or neurological disorder.I have had cancer within the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: traumatic amputation of the hand
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the clinical trial accept participants under 20 years of age?
"This medical trial allows for the recruitment of individuals aged 18 or above and below 60 years old."
Answered by AI
Are there any open slots for people to join this research initiative?
"Affirmative. Per the data on clinicaltrials.gov, this trial is actively recruiting patients and was first posted on January 1st 2023. An update was applied to the study most recently on May 12th 2022 and 100 people are being recruited at a single site."
Answered by AI
Who meets the criteria to partake in this research investigation?
"This clinical trial has a limited capacity of 100 subjects and is exclusively open to amputees aged 18-60."
Answered by AI
How many participants are being enrolled in this exploration?
"Indeed, according to clinicaltrials.gov, this medical trial is actively enlisting volunteers. It was first published on January 1st 2023 and has been recently updated as of May 12th 2022; currently, 100 individuals need to be recruited from a single site."
Answered by AI
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