Septoplasty Clinical Trial
— NOSEOfficial title:
Validation of a Process for the Manufacture of Stem Cells Isolated From the Nasal Cavity for Innovative Cell Therapy of Traumatized Peripheral Nerves
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.
| Status | Recruiting |
| Enrollment | 25 |
| Est. completion date | August 10, 2021 |
| Est. primary completion date | February 10, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service d'Oto-Rhino-Laryngologie - Conception - AP-HM | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | absence of caryotipic abnormalities during their amplification | 24 months |
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