Clinical trial • Phase I • Neurology
Adipose-derived stromal vascular fraction (autologous) for Inclusion body myositis
Phase I trial of Adipose-derived stromal vascular fraction (autologous) for Inclusion body myositis. None/Not specified-controlled. 38 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Inclusion body myositis
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 03-10-2024
- First CTIS Authorization Date
- 24-10-2024
Trial design
None/Not specified-controlled Phase I trial across 10 sites in France.
- Comparator
- None/Not specified
- Target Sample Size
- 38
Recruitment
- Planned Sample Size
- 38
- Recruitment Window Months
- 70
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 38
France
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 24-10-2024
- Processing Time Days
- 10
- Number Of Sites
- 10
- Number Of Participants
- 38
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Centre de thérapie cellulaire
- Contact Person Name
- Julie VERAN
- Contact Person Email
- julie.veran@ap-hm.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Centre d'investigation neuromusculaire
- Contact Person Name
- Yves FROMES
- Contact Person Email
- y.fromes@institut-myologie.org
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Immunologie et thérapie cellulaire
- Contact Person Name
- Camille GIVERNE
- Contact Person Email
- camille.giverne@chu-rouen.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Chirurgie de la main - Chirurgie plastique réparatrice des membres
- Contact Person Name
- Dominique CASANOVA
- Contact Person Email
- Dominique.CASANOVA@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Service de Chirurgie plastique et de la main
- Contact Person Name
- Isabelle AUQUIT-AUCKBUR
- Contact Person Email
- Isabelle.auquit@chu-rouen.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Centre d'Investigation Neuromusculaire
- Contact Person Name
- Yves FROMES
- Contact Person Email
- y.fromes@institut-myologie.org
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de neuromyologie
- Contact Person Name
- Olivier BENVENISTE
- Contact Person Email
- olivier.benveniste@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Médecine interne et immunologie clinique
- Contact Person Name
- Olivier BENVENISTE
- Contact Person Email
- olivier.benveniste@aphp.fr
- Site Name
- Aix Marseille University
- Department Name
- Centre de Résonance Magnétique en Biologie et Médecine
- Contact Person Name
- Maxime GUYE
- Contact Person Email
- maxime.guye@ap-hm.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Centre de référence des maladies neuromusculaires
- Contact Person Name
- Shahram ATTARIAN
- Contact Person Email
- Shahram.ATTARIAN@ap-hm.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- autologous uncultured Adipose-Derived Stromal Vascular Fraction (ADSVF)
- Active Substance
- Adipose-derived stromal vascular fraction (autologous)
- Modality
- Cell therapy
- Routes Of Administration
- Intramuscular
- Route
- Intramuscular
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