Informations générales (source: ClinicalTrials.gov)
Validation of a Process for the Manufacture of Stem Cells Isolated From the Nasal Cavity for Innovative Cell Therapy of Traumatized Peripheral Nerves (NOSE)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
décembre 2018
août 2021
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service d'Oto-Rhino-Laryngologie - Conception - AP-HM - 13354 - Marseille - France | Patrick DESSI | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
- 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)
- 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