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Muscle Cell Mediated Therapy for Tongue Dysphagia: An Investigation of Cook MyoSite Autologous Muscle Derived Cells
The primary objective of this study is to evaluate the safety of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.
Details
| Lead sponsor | Peter Belafsky, MD |
|---|---|
| Phase | Phase 1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 18 |
| Start date | 2017-05-24 |
| Completion | 2026-12 |
Conditions
- Oropharyngeal Dysphagia
Interventions
- Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR)
Primary outcomes
- Study product-related Serious Adverse Events (SAEs) — 24 months
Evaluate the safety of AMDC-GIR following treatment of tongue dysphagia - Study product-related, biopsy procedure-related, and injection procedure-related adverse events — 24 months
Safety will be determined by the frequency and severity of adverse events related to study procedures and study product
Countries
United States