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Clinical Research Res.
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Product development and early clinical chronic wound studies with living allogeneic dermal fibroblasts on biodegradable microcarriers in a gel* First Author: Peter Lagosky Authors: P.A. Lagosky, J. Xu, S. Top-Lapid, N. S. Bashir, J. Connelly Development and manufacturing control of complex cell-based treatments for chronic wounds such as diabetic foot ulcers is challenging. A novel topical product consisting of living allogeneic human dermal fibroblasts on biodegradable microcarriers composed of cross-linked porcine gelatin and formulated in a gel storage matrix* that preserves viability at ambient temperature is being progressed. The clinical product was manufactured for Phase I studies in continuously run, single-step cell culture. A two-stage cGMP-compliant process was worked up to provide supplies for clinical trials and for marketing, with markedly improved product yields, process consistency, product availability, and process scalability. In a Phase I clinical study, subjects had a partial or full-thickness non-infected neuropathic diabetic foot ulcer present for at least two weeks at randomization. The controlled, open label, tiered study had thirty-six subjects receiving a single application, or four weekly applications, of one of three fibroblast concentrations of the product plus standard of care (SOC), or SOC alone. The study established safety of the product and suggested efficacy in chronic, hard-to-heal diabetic foot ulcers. Most adverse events reported were determined to be unrelated to the product. The treatment is currently being studied in a pivotal trial. *Product notation: Regenadermª, ApoPharma, Inc. Toronto, ON |
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