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Gintuit, Autologous palatal tissue · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Gintuit | DEVICE | Application of Gintuit at Day 0 to the gingival bed |
| Autologous palatal tissue | OTHER | Tissue will be harvested from the subject's palate and placed on the gingival bed |
Gintuit, also known as Autologous palatal tissue, is used for gingival recession, a condition where gum tissue pulls away from the teeth. It is being developed as a treatment for oral soft tissue regeneration. The drug is currently in Phase 3 clinical development and is considered investigational.
Gintuit is an autologous palatal tissue product, meaning it is derived from the patient's own palatal tissue. It is designed to promote oral soft tissue regeneration, specifically addressing gingival recession. The exact molecular target is not specified, but its mechanism involves using the patient's own tissue to aid in regeneration.
Gintuit is developed by Organogenesis Holdings Inc., a biopharmaceutical company. The company's stock ticker is ORGO. Organogenesis is focused on advanced wound care and surgical biologics, and Gintuit is one of its investigational products for oral soft tissue regeneration.
Gintuit is in Phase 3 clinical development. It has completed one Phase 3 trial, and there are no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities. Its development status indicates it is still in the clinical trial phase.
Gintuit has been studied in a Phase 3 clinical trial with the identifier NCT00587834, titled 'Safety and Efficacy of Gintuit(TM) for Oral Soft Tissue Regeneration.' This trial, which enrolled 96 participants, has been completed. The trial was uncontrolled and did not use randomization or blinding.
Yes, Gintuit is also known as Autologous palatal tissue. This alternative name reflects that the product is derived from the patient's own palatal tissue. Both names refer to the same investigational treatment for gingival recession, developed by Organogenesis Holdings Inc.