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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Septoplasty Turbinoplasty | Procedure: biopsy of mucosa's olfactory | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Validation of a Process for the Manufacture of Stem Cells Isolated From the Nasal Cavity for Innovative Cell Therapy of Traumatized Peripheral Nerves |
Actual Study Start Date : | December 10, 2018 |
Estimated Primary Completion Date : | February 10, 2021 |
Estimated Study Completion Date : | August 10, 2021 |
Arm | Intervention/treatment |
---|---|
patients with biopsy |
Procedure: biopsy of mucosa's olfactory
intervention under general or local anesthesia
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patrick DESSI | 33(0)4 91 43 55 20 | patrick.dessi@ap-hm.fr |
France | |
Service d'Oto-Rhino-Laryngologie - Conception - AP-HM | Recruiting |
Marseille, France, 13354 | |
Contact: Patrick DESSI 33(0)4 91 43 55 20 patrick.dessi@ap-hm.fr |
Study Director: | Jean-Olivier ARNAUD | AP-HM |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | July 11, 2019 | ||||
First Posted Date ICMJE | July 16, 2019 | ||||
Last Update Posted Date | July 16, 2019 | ||||
Actual Study Start Date ICMJE | December 10, 2018 | ||||
Estimated Primary Completion Date | February 10, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
absence of caryotipic abnormalities during their amplification [ Time Frame: 24 months ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Validation of a Process for the Manufacture of Stem Cells Isolated From the Nasal Cavity for Innovative Cell Therapy of Traumatized Peripheral Nerves | ||||
Official Title ICMJE | Validation of a Process for the Manufacture of Stem Cells Isolated From the Nasal Cavity for Innovative Cell Therapy of Traumatized Peripheral Nerves | ||||
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 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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | Procedure: biopsy of mucosa's olfactory
intervention under general or local anesthesia
|
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Study Arms ICMJE | patients with biopsy
Intervention: Procedure: biopsy of mucosa's olfactory
|
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
25 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 10, 2021 | ||||
Estimated Primary Completion Date | February 10, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
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Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04020367 | ||||
Other Study ID Numbers ICMJE | 2018-40 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Assistance Publique Hopitaux De Marseille | ||||
Study Sponsor ICMJE | Assistance Publique Hopitaux De Marseille | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
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PRS Account | Assistance Publique Hopitaux De Marseille | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |