July 10, 2018 Source: Verdict Medical Devices 212
Viscofan BioEngineering, a German medical products manufacturer is to conduct a Phase I clinical trial of its stem cell implant, VB-C01, designed to treat severe cardiac insufficiencies, on receiving a green light from the Spanish Agency for Medicines (AEMPS).
The regenerative medicine is a biocompatible collagen cell carrier that carries stem cells and can also hold other therapeutic cells thereby providing a natural scaffold for cellular recolonization of severely damaged tissues.
The trial will be conducted on 10 subjects with ischemic cardiomyopathy who will receive the stem cell implant. Existing implants have failed to produce consistent efficacy profile in trials, resulting in a dearth of successful treatment options for this condition.
The principal investigator of the trial, Fernández-Avilés said: “The product developed by Viscofan BioEngineering is a 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.”
The affected heart tissue showed increased cell survival, local-specific efficacy, elasticity and vascularisation through the direct approach in preclinical testing. The collagen membrane is also reported to have positive effects on heart functionality.
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.”By Ddu
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