BridgeMD
New treatment option for Amputation, Traumatic
Official title Human Upper Extremity Allotransplantation
ClinicalTrials.gov ID: NCT01459107
What this study is testing
What is Bone marrow cell-based therapy & single-drug immunosuppression.?
Bone marrow cell-based therapy & single-drug immunosuppression. is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for amputation, traumatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- Recipient
- Recent (≥6 months) or remote (i.e., several decades) unilateral or bilateral upper limb loss (below the shoulder) desiring limb transplantation.
- Below-shoulder amputation.
- Functionless or minimally functional hand desiring removal of functionless / minimally functional hand followed by transplantation.
- Male or female and of any race, color or ethnicity.
You likely can't join if
- below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks...
- No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
- Negative for malignancy for past 5 years.
- Negative for HIV at transplant.
- Negative crossmatch with donor.
- If female of child-bearing potential, negative serum pregnancy test.
See the full eligibility criteria
- Recipient
- Recent (≥6 months) or remote (i.e., several decades) unilateral or bilateral upper limb loss (below the shoulder) desiring limb transplantation.
- Below-shoulder amputation.
- Functionless or minimally functional hand desiring removal of functionless / minimally functional hand followed by transplantation.
- Male or female and of any race, color or ethnicity.
- Aged 18-69 years.
- Completes the protocol informed consent form.
- No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (see Donor and Recipient
- below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of upper extremity transplantation.)
- No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
- Negative for malignancy for past 5 years.
- Negative for HIV at transplant.
- Negative crossmatch with donor.
- If female of child-bearing potential, negative serum pregnancy test.
- If female of child-bearing potential, consent to use reliable contraception for at least one year following transplantation.
- Consents to bone marrow infusion as part of the treatment regime.
- USA citizen or equivalent, or foreigner with documentation of ability to pay for transplant and required follow-up care.
- Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime. Donor Inclusion Criteria: Donors will be selected by the upper extremity transplant team in conjunction with...
- Brain dead meeting the criteria for Determination of Death.
- Family consent for limb donation.
- Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure).
- Aged 16 - 65 years.
- Limb matched for size with recipient.
- Same blood type as recipient.
- Negative lymphocytotoxic crossmatch.
- Accurately matched for gender, skin tone, and race (relative requirements depending on recipient consent). Exclusion Criteria:
- Positive for any of the following conditions:
- Untreated sepsis.
- HIV (active or seropositive).
- Active tuberculosis.
- Hepatitis B or C.
- Viral encephalitis.
- Toxoplasmosis.
- Malignancy (within past 5 years).
- Current/recent (within 3 months of donation/screening consent) IV drug abuse.
- Paralysis of ischemic or traumatic origin.
- Inherited peripheral neuropathy.
- Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.
- Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).
- Mixed connective tissue disease.
- Severe deforming rheumatoid or osteoarthritis in the limb. Donor Only:
- Tattoos:
- Non-professional tattoo within last 6 months, or
- Personally identifiable tattoo (i.e., donor name) on potential transplant. Recipient Only:
- Type I (insulin-dependent) diabetes mellitus
- Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.
- Sensitized recipients with high levels (50%) of panel-reactive human leukocyte antigen (HLA) antibodies.
- Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S...
- Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery.
- Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like osteopetrosis.
- Patients considered unsuitable per the consulted Psychiatrists appraisal.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.