Status:

UNKNOWN

Validation of a Process for the Manufacture of Stem Cells Isolated From the Nasal Cavity for Innovative Cell Therapy of Traumatized Peripheral Nerves

Lead Sponsor:

Assistance Publique Hopitaux De Marseille

Conditions:

Septoplasty

Turbinoplasty

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Despite progress in the time taken to take charge and in the quality of the surgical technique, the repair of damaged peripheral nerves has not improved in the last twenty years. Faced with these limi...

Eligibility Criteria

Inclusion

  • Major adults men or women
  • Affiliated to a social security scheme.
  • Absence of contraindication to general and / or local anesthesia
  • Relevant to an operative indication of functional surgery of the nose (septoplasty and / or turbinoplasty)

Exclusion

  • Patients with proven organic pathologies of the nervous system
  • Pregnant and / or lactating women
  • Persons deprived of their liberty
  • Major under guardianship
  • persons unable to read the information document.
  • Patients with chronic inflammatory and / or infectious rhinosinusitis
  • Patient under antithrombotic therapy
  • Patient with hypersensitivity to local amide-bound anesthetics (such as lidocaine) or to any of the components, including methyl parahydroxybenzoate contained in the vehicle.
  • Patient with porphyria.
  • Patient with epilepsy not controlled by treatment.
  • Patient with a history of surgery on the ethmoid and / or the average turbinate bilaterally.
  • Patient with a history of cervico-cephalic radiotherapy

Key Trial Info

Start Date :

December 10 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 10 2021

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT04020367

Start Date

December 10 2018

End Date

August 10 2021

Last Update

July 16 2019

Active Locations (1)

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1

Service d'Oto-Rhino-Laryngologie - Conception - AP-HM

Marseille, France, 13354