Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT05857358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Study Overview
Official Title:
Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia (XEROCELL)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XEROCELL
Brief Summary:
The main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (D14).
Detailed Description:
Autoimmune xerostomia is a disabling condition affecting mostly patients suffering from Sjögren's disease, systemic lupus erythematosus, rheumatoid arthritis and systemic xerostomia.
Local therapies and systemic drug treatments (picarpine) remain the gold standards but have limited effects upon salivary flow action and many adverse effects.
Stem cell therapies and notably adipose tissue-derived stromal cells have shown promising potential for tissue repair. Autologous uncultured adipose-derived stromal vascular fraction (AD-SVF) is recognized as an easily accessible (by a standard lipoaspiration to obtain adipose tissue, from which AD-SVF are isolated by centrifugation), safe and well tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties.
The purpose of our AD-SVF phase I trial is to evaluate, first the tolerance of autologous AD-SVF cells locally injected in the oral cavity and second their capability to improve the salivary function.
Local therapies and systemic drug treatments (picarpine) remain the gold standards but have limited effects upon salivary flow action and many adverse effects.
Stem cell therapies and notably adipose tissue-derived stromal cells have shown promising potential for tissue repair. Autologous uncultured adipose-derived stromal vascular fraction (AD-SVF) is recognized as an easily accessible (by a standard lipoaspiration to obtain adipose tissue, from which AD-SVF are isolated by centrifugation), safe and well tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties.
The purpose of our AD-SVF phase I trial is to evaluate, first the tolerance of autologous AD-SVF cells locally injected in the oral cavity and second their capability to improve the salivary function.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: