BMAC Nerve Allograft Study

Brooke Army Medical Center

Status: Unknown

Conditions: Peripheral Nerve Injury Upper Limb

Treatments: Procedure: Avance Nerve Graft with Autologous BMAC

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT03964129

C.2017.074

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Avance Nerve Graft with autologous BMAC

Experimental group

Description:

The Avance Nerve Graft will be inserted in the area of nerve injury. Between 40 to 60 ml of Bone Marrow Aspirate from the anterior or posterior iliac crest of the pelvis will be harvested . Using SmartPrep centrifuge and 60 ml BMAC kit, 7 to 10 ml of final BMAC will be obtained.

Treatment:

Procedure: Avance Nerve Graft with Autologous BMAC