Official Title
An Open-Label Study Using NTX-001 to Repair Peripheral Nerve Transection(s)
Brief Summary

The proposed use of NTX-001 for transections of peripheral nerves in the upper extremity for subjects that don't qualify for study NTx20201.

Detailed Description

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


Intermediate-size Population
Treatment IND/Protocol
Peripheral Nerve Injury Upper Limb

Combination Product: NTX-001
One-time use surgical product of three solutions and a device

Eligibility Criteria

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.

Eligibility Gender
Eligibility Age
Minimum: 16 Years~Maximum: 80 Years
United States

Orlando Health Orthopedic Institute
Orlando, Florida, 32806


Investigator: Karan A Desai, MD
Contact: 321-843-5851

Investigator: David J Krol, CRC
Contact: 321-843-5687

Washington University - Division of Plastic and Reconstructive Surgery
Saint Louis, Missouri, 63110


Investigator: Thomas H Tung, MD
Contact: 314-362-4588

Investigator: Kelly Koogler, BSN RN
Contact: 314-362-4639


Seth Schulman, MD

Neuraptive Therapeutics Inc.
NCT Number
MeSH Terms
Peripheral Nerve Injuries