Clinical trial NCT03964129: BMAC Nerve Allograft Study
Official title: Clinical Evaluation of Decellularized Nerve Allograft With Autologous Bone Marrow Aspirate Concentrate (BMAC) to Improve Peripheral Nerve Repair and Functional Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Nerve Injury Upper Limb
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: Walter Reed National Military Medical Center
name: Curtis National Hand Center at MedStar Union Memorial Hospital
name: Cleveland Clinic Lerner Research Institute
First posted: 2019-05-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, multi-center, proof of principle, phase I human safety study evaluating the sequential treatments of the Avance Nerve Graft, a commercially available decellularized processed peripheral nerve allograft, with autologous Bone Marrow Aspirate Concentrate (BMAC), a source of stem cells, for the repair of peripheral nerve injuries up to 7 cm in length. The purpose of this study is to establish a knowledge product, evaluating the safety profile of the Avance Nerve Graft, followed by the application of BMAC to support further investment into the promising area of using stem cells in conjunction with scaffolds.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female 18 to 74 years of age.
* Undergoing peripheral nerve exploration or grafting with allograft in the upper extremity.
* Subjects must be inpatients or scheduled for surgery at the time of study enrollment.
* Has nerve conduction block injuries to the ulnar, median, radial or musculocutaneous nerve of either upper extremities that is less than two years from injury.
* Be willing to undergo tension free end-to-end nerve graft coaptation on both the proximal and distal portion of the nerve gap with the Avance Nerve Graft.
* Be willing to have bone marrow harvested from own body, concentrated, and applied to the site of nerve injury following the insertion of the Avance Nerve Graft.
* Be willing to participate and able to comply with all aspects of the treatment and evaluation schedule over a 18-month duration.
* Capable of giving their own consent to participate in the study, and willing to sign and date an IRB-approved written informed consent prior to initiation of any study procedures.
* Nerve conduction injury affecting sensory and motor function or solely motor function in the upper extremity.
* Nerve gaps following resection, up to 7 cm, inclusive.

Exclusion Criteria:

* Subjects with Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus requiring regular insulin therapy.
* Subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system.
* History of neurodegenerative disease, neuropathy, or diabetic neuropathy.
* History of chronic ischemic condition of the upper extremity.
* Cognitive limitation or mental illness preventing informed consent.
* Nerve injuries \>2 years post initial injury.
* Any participant who at the discretion of the Investigator is not suitable for inclusion in the study.

Primary outcomes:
measure: Comparison of the nature and incidence of AEs between the group of subjects receiving Avance Nerve Graft with BMAC and the historical data of nerve repairs with the Avance Nerve Graft.
timeFrame: 18 months
Secondary outcomes:
measure: Test of non-inferiority and superiority of Avance Nerve Graft to historical nerve autograft scores with respect to Rosen-Lundborg using closed testing procedures
timeFrame: 18 months
measure: Test of non-inferiority of Avance Nerve Graft plus BMAC to Avance Nerve Graft recovery rates with respect to Rosen-Lundborg scores using closed testing procedures
timeFrame: 18 months
Other outcomes:
measure: Comparison of Motor Percent Recovery to Baseline Range of Motion
timeFrame: 18 months
measure: Comparison of Motor Percent Recovery to Baseline Grip Strength
timeFrame: 18 months
measure: Comparison of Motor Percent Recovery to Baseline Pinch Strength
timeFrame: 18 months
measure: Time to Recovery
timeFrame: 18 months
measure: Functional Outcomes through the assessment of Quick Disabilities of the Arm Shoulder and Hand (QuickDASH) questionnaire
timeFrame: 18 months
measure: Functional Outcomes through the assessment of Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 18 months
measure: Motor and Sensory Nerve Conduction Studies (Nerve Conduction Velocity (NCV) and/or Electromyography (EMG))
timeFrame: 12 and 18 month
measure: Comparison of Sensory Percent Recovery to Baseline
timeFrame: 18 months
Locations:
city: Baltimore
country: United States
facility: Curtis National Hand Center at MedStar Union Memorial Hospital
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Julia Nuelle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed National Military Medical Center
name: Leon J Nesti, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Curtis Hand Center at MedStar Union Memorial Hospital
name: Kenneth Means, MD
role: PRINCIPAL_INVESTIGATOR
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