German medical products developer Viscofan BioEngineering has secured approval from the Spanish Agency for Medicines (AEMPS) to conduct a Phase I clinical trial of its stem cell implant called VB-C01, designed to treat severe cardiac insufficiency.
The regenerative medicine consists of a biocompatible, elastic collagenous membrane that carries the stem cells. This collagen carrier can also hold other therapeutic cells and provides a natural scaffold for cellular recolonisation of severely damaged tissues.
During the Phase I trial, the stem cell implant will be evaluated in ten subjects with ischemic cardiomyopathy, which lacks successful treatments due to the failure of existing implants to demonstrate consistent efficacy profile in trials.
Trial principal investigator Fernández-Avilés said: “The product developed by Viscofan BioEngineering is pioneer in using a robust, nature-like and biodegradable support to deliver the cells to the heart.
“In contrast to existing approaches where cells are injected into the heart tissue, the cells previously attach to the collagen matrix and form a robust cell-matrix association that is then sutured directly to the site of the damaged tissue.”
In preclinical testing, the direct approach is said to have increased cell survival, local-specific efficacy, elasticity and vascularisation of the affected heart tissue. The collagen membrane is also reported to have significantly improved heart functionality.
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Viscofan BioEngineering corporate manager Lluís Quintana said: “This is a very important milestone for Viscofan in the development of its biomedical division.
“This project is of particular significance because of the tremendous need cardiomyopathy patients have and because of the excellence of the clinical partners that are involved in this international initiative.”
A division of Naturin Viscofan, Viscofan BioEngineering develops collagen products for new surgical procedures, advanced medical devices, tissue engineering and improved nutraceuticals.