Cell in Cells Receives IND Approval for Organoid Skin Regeneration Treatment
Jae-jin Cho, CEO of Cell in Cells, announced on the 16th that the company has obtained approval for its clinical trial plan (IND) from the Food and Drug Safety Administration. This approval is for their first pipeline, a new drug candidate called TRTP-101, which aims to revolutionize organoid skin regeneration treatment using stem cells.
Cell in Cells is a pioneering bio venture founded by Professor Cho Jae-jin, renowned for his expertise at Seoul National University’s School of Dentistry. The company focuses on research and development (R&D) of advanced regenerative therapy, leveraging their innovative tissue modification technology platform.
TRTP-101, the drug that received IND approval, is developed from human-derived stem cells that are transformed into organoids using state-of-the-art 3D tissue morphology technology. When these organoids are transplanted into atrophic scars where the skin is depressed, the treatment rejuvenates the damaged skin tissue.
Atrophic scarring is a debilitating condition caused by a localized reduction in skin tissue resulting from poor wound healing or inflammation. Besides physical discomfort, patients with atrophic scars often experience psychological distress, including depression, anxiety, and social withdrawal, due to the impact on their daily lives and self-esteem.
The Cell in Cells’ organoid skin regeneration treatment, classified as an “innovative new technology,” aligns with the national strategic technology guideline published by the Korean government in June. This guideline recognizes the contribution of organoid differentiation and culture technology in developing and manufacturing high-quality regenerative treatments.
With this IND approval, Cell in Cells can now embark on clinical trials to assess the effectiveness of their atrophic scarring treatment. The company aims to accelerate the development and commercialization of their skin regeneration treatments. Park Hye-jeong, head of Cell in Cells’ clinical development department, said, “This milestone marks a significant step forward in the development of organoid skin regeneration treatment. Our plan is to complete phase 3 clinical trials for TRTP-101 by 2026 and submit an IND application to the US Food and Drug Administration (FDA) in 2027.”
Cell in Cells’ breakthrough in organoid-based regenerative therapy brings hope for those suffering from atrophic scarring. Their pioneering approach has the potential to enhance not only physical appearance but also the overall well-being of patients.
Cell in Cells (CEO Jae-jin Cho) announced on the 16th that it had received approval for a clinical trial plan (IND) from the Food and Drug Safety Administration on the 7th for its first pipeline (new drug candidate), organoid skin regeneration treatment stem cell ‘TRTP-101’
Cell in Sells is a bio venture founded by Professor Cho Jae-jin from Seoul National University’s School of Dentistry. Research and development (R&D) of advanced regenerative therapy (Advanced Regenerative Therapy) based on the tissue modification technology platform (Tissue Modification Technology Platform).
In particular, the Cell in Cell organoid skin regeneration treatment has been approved as an ‘innovative new technology’ which corresponds to ‘organoid differentiation and culture technology applied to the development and manufacture of a high quality organoid regeneration treatment’ as defined in the Senior National. Strategic Technology published in June (Technology)’.
TRTP-101, which received IND approval this time, is made from human-derived stem cells into organoids using 3D tissue morphology technology. When transplanted into an atrophic scar where the skin is depressed, the skin tissue is regenerated.
Atrophic scarring is a disease in which the skin sags due to a local reduction in skin tissue due to a lack of wound healing or inflammation. It has been investigated that patients with atrophic scars not only suffer from discomfort due to skin changes, but also suffer from secondary side effects such as depression, anxiety, and social avoidance due to a reduction in daily life and self-esteem.
Through this clinical trial, Cell in Cells intends to test the effect of atrophic scarring treatment and seriously advance the development and commercialization of skin regeneration treatments. “With this IND approval, the basis for the development of an organoid skin regeneration treatment has been laid,” said Park Hye-jeong, head of Cell in Cells’ clinical development department (executive director). He added, “We plan to complete phase 3 clinical trials for TRTP-101 by 2026 and apply for an IND to the US Food and Drug Administration (FDA) in 2027.”
Cho Jae-jin, CEO of Sell in Sells / Photo = Sell in Sells
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