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

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 limitations of surgical treatment, multidisciplinary teams from Marseille and Rouen have come together to propose an innovative approach to cell therapy that can limit inflammation and improve axonal growth.

Cell transplantation now appears as an alternative to treat nerve damage. Scientific advances have shown in animal models as well as in humans that mesenchymal stem cells are good cellular candidates for supporting nerve regeneration after transplantation. On the other hand, their collection requires an invasive sample most often of bone marrow. A new stem cell candidate capable of stimulating nerve regeneration has recently been identified in the olfactory mucosa located in the nasal cavity. These cells are part of the "ecto-mesenchymal" stem cell family. They have biological characteristics very similar to those of mesenchymal stem cells of the bone marrow.

They exhibit high mitogenic activity and have a high potential for differentiation towards neural lineages. Given their properties and ease of access within the nasal cavity, ecto-mesenchymal stem cells offer new perspectives for cell therapy targeting nerve damage.

In this context, nasal ecto-mesenchymal stem cells represent an interesting reconstruction alternative, particularly in the indication of peripheral nerve lesions. They are directly and easily accessible to any individual. We therefore propose in this study to validate a method of manufacturing isolated stem cells from a biopsy of a few cubic millimeters of the nasal cavity of adults, taken during a surgical procedure, with a view to proposing shortly an innovative cell therapy. From each nasal biopsy taken, the cells will be amplified in vitro under pharmaceutical grade conditions and then controlled, validated and characterized in particular for their ability to differentiate into neural cells and for their lack of genetic instability. The cells will also be cryo-preserved and then thawed under pharmaceutical grade conditions in order to validate the maintenance of their quality after cryopreservation allowing to propose a delayed implantation according to the clinical context. This study requires the taking of 25 biopsies of nasal mucosa taken from adults to document the reproducibility of the manufacturing process and possible inter-donor variations. This validation data is an essential step before considering a clinical trial of Innovative Cell Therapy Drugs.

Study Overview

• Status: Unknown
• Conditions: Septoplasty; Turbinoplasty
• Intervention / Treatment: Procedure: biopsy of mucosa's olfactory

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick DESSI; Phone Number: 33(0)4 91 43 55 20; Email: patrick.dessi@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Service d'Oto-Rhino-Laryngologie - Conception - AP-HM
    • Contact: Patrick DESSI; Phone Number: 33(0)4 91 43 55 20; Email: patrick.dessi@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients with biopsy	Procedure: biopsy of mucosa's olfactory; intervention under general or local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
absence of caryotipic abnormalities during their amplification	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Anticipated): February 10, 2021
• Study Completion (Anticipated): August 10, 2021

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No