The proposed use of NTX-001 for transections of peripheral nerves in the upper extremity for subjects that don't qualify for study NTx20201.
The proposed procedure would employ NTX-001 as a free functional muscle transfer to the upper extremity. This procedure is meant to restore the function of one or two joints in the upper extremity by bringing the gracilis muscle from the leg with its associated obturator nerve and its vascular pedicle. Most commonly, and in this case, as well, elbow flexion is the main function that is targeted for improvement. This is for a brachial plexus injury, and therefore we would be using an extraplexal nerve as a donor nerve to reinnervate the gracilis muscle. Most commonly, this is the spinal accessory nerve. The only proposed direct tension-free coaptation that would be subject to NTX-001 is the spinal accessory nerve to the obturator nerve. The benefit of this would be immediate reinnervation of the gracilis in the arm without a period of muscle atrophy that traditionally occurs with this operation. Usually, the first signs of any muscle contraction occur around 6 months when the patient tries to flex their elbow. With NTX-001, this may be significantly expedited with early return of function and result in greater muscle strength due to the prevention of muscle atrophy.
Combination Product: NTX-001
One-time use surgical product of three solutions and a device
Inclusion: - The subject is between 16 and 80 years of age. - The subject has clinical evidence of an acute peripheral nerve transection from conditions or interventions that have or may result in motor or sensory impairment amendable to surgical repair.
Exclusion: - Subjects whose nerve repair will occur greater than 48 hours after nerve transection. - Subjects on chronic corticosteroid therapy within 14 days of repair. - The subject is pregnant and/or is breastfeeding. - The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.
Orlando Health Orthopedic Institute
Orlando, Florida, 32806
Investigator: Karan A Desai, MD
Investigator: David J Krol, CRC
Seth Schulman, MD