Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Major Extremity Trauma Research Consortium
Study ID
NCT04789044
Phase
PHASE2
Status
Recruiting
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Conditions

  • Peripheral Nerve Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • NTX-001 — DRUG
    • PEG fusion is the application of a polyethylene glycol (PEG) using a combination of sequenced reagents to a freshly performed nerve coaptation, or neurorrhaphy, to allow the axonal membranes of the proximal and distal axonal stumps to fuse back together and re-establish full axonal continuity.

Study Details

The overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper extremity peripheral nerve injury. PEG is safe and effective for extending the half-life of circulating pharmaceutical products, when used in conjunction with a topical hemostatic agent in surgical wounds, and when used as a colon cleanser for endoscopic surgical procedures. However, PEG fusion has not been rigorously tested as a safe reagent to promote nerve regeneration in humans. Therefore, the goal of this Phase 2a clinical trial is to establish safety data and to examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function. Results will be externally validated using data collected in the DoD funded prospective NERVE study and will provide preliminary evidence to power a larger phase II efficacy trial.

Key Dates

Start date
Jun 1, 2023
Status verified
Feb 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PEG mediated reconstruction
    NTX-001 will be administered topically via isolation chamber medical device. Dose Unit: 2.5 mL NTX-001 is a single use surgical product intended for use as adjunct treatment in the repair of severed peripheral nerves in patients requiring standard suture neurorrhaphy.
  • No Intervention: Conventional nerve reconstruction
    Conventional nerve reconstruction

Primary Outcome Measure

Complications or problems that occur with in the first 30 days. [ Time Frame: Up to 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21213
Jaimie Shores, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Medical Center Shock Trauma CenterBaltimoreMaryland21201
Ray Pensy, MD (PRINCIPAL_INVESTIGATOR)
Cooper HealthCamdenNew Jersey08103
Pietro Gentile
[email protected]
David Fuller, MD (PRINCIPAL_INVESTIGATOR)
OrthoCarolinaCharlotteNorth Carolina28207
Glenn Gaston, MD (PRINCIPAL_INVESTIGATOR)
Wellspan HealthYorkPennsylvania17403
Richard Trevino, MD (PRINCIPAL_INVESTIGATOR)
San Antonio Military Medical Center (SAMMC)San AntonioTexas78234
Jason Alderete, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth University Medical CenterRichmondVirginia23219
Jonathan Issacs, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University School of Medicine· Baltimore, MDUniversity of Maryland Medical Center Shock Trauma Center· Baltimore, MDCooper Health· Camden, NJOrthoCarolina· Charlotte, NCWellspan Health· York, PASan Antonio Military Medical Center (SAMMC)· San Antonio, TX

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