__hot__ - Rctd-444

| Component | Description | Role in the Patch | |-----------|-------------|-------------------| | | Induced pluripotent stem cells (iPSCs) reprogrammed from a patient’s peripheral blood or skin fibroblasts, then differentiated into mature cardiomyocytes. | Provide the contractile muscle cells that will integrate with the host myocardium. | | Self‑assembling peptide hydrogel (SAPH) | A synthetic, biodegradable scaffold that mimics the extracellular matrix of the heart. | Offers mechanical support, promotes cell alignment, and degrades harmlessly over 8–12 weeks. | | CRISPR‑based epigenetic enhancer (CR‑E4) | A transient, non‑viral CRISPR‑Cas9 system that activates a suite of pro‑survival and pro‑angiogenic genes (e.g., VEGF‑A , HIF‑1α , CXCL12 ) without permanent genomic alteration. | Boosts cell survival after implantation and encourages rapid vascularization of the patch. |

The at IRC is already in early dialogue with the FDA’s Office of Cellular, Tissue, and Gene Therapies (OCTGT), leveraging the agency’s 2022 guidance on combination products (cellular + device + gene‑editing) to streamline the review. RCTD-444