Colombia's Keraderm and Interventional Concepts join forces for a first-in-human trial to validate a technology to remodel and reconstruct skin tissue
Keraderm, an innovative product to heal skin defects based on cultures of keratinocytes and fibroblasts, developed in Colombia by Dr. Rodrigo Soto, Jennifer Gaona and Juan Zambrano, has joined forces with Interventional Concepts to design and manage a clinical study in humans. The study results will allow the product to be approved for commercialization by Colombia's Invima and other international regulatory bodies as a requirement for global expansion.
Keraderm SAS, a company known in Colombia for its revolutionary Keraderm product, has partnered with Interventional Concepts to design and manage a clinical study in humans. Keraderm's goal is to submit the study data to Colombia's National Institute of Food and Drug Monitoring (INVIMA) for its innovative product that covers defects in the skin, remodels and rebuilds human tissue. The study will begin in early 2016 at Hospital Universitario San Ignacio in Bogotá, Colombia. The hospital is one of the most prestigious in Colombia, was founded 70 years ago and is affiliated to Javeriana University.
The study will be led by Dr. Maria Fernanda Lopez, Interventional Concept's director of clinical studies, and will take place for about a year. Keraderm has already demonstrated product safety and efficacy in previous tests, "our product has treated over 130 patients in different hospitals in Bogota," said Dr. Rodrigo Soto.
Keraderm, the cure for wounds: Keraderm is the result of years of work by doctor Rodrigo Soto, Jennifer Gaona, and Juan Zambrano, who in 2008 had the idea of using keratinocytes and fibroblasts from a patient to obtain a sheet of skin to allow treatment of burn trauma, tumors, and ulcers. "Keraderm consists of skin-cell-coated 10 × 10 cm plates, grown from a 5 mm sample of healthy skin from the same patient. It is a painless nonsurgical procedure which treats in a short period of time with significant cost reduction, " explained Dr. Rodrigo Soto.
Keraderm is also useful for the reconstruction of burned tissue caused by acid burns. Colombia is one of the leading countries in the number of acid attacks; a crime in which the victim —almost always a woman— gets acid poured on the face or the body. The victims —35 in 2013— also suffer from physical pain and strong psychological trauma that greatly affects their self-esteem. According to Keraderm founders, "Keraderm is definitely an option for the treatment of acid burns, but it is important to note that is complementary to many other additional treatments that the victims should receive."
Keraderm works by removing a skin sample behind the patient's ear and then taking a blood sample. Both samples are sent to Keraderm's lab where technicians create a culture of keratinocytes and fibroblasts. Keratinocytes are abundant keratin cells which stimulate the growth of epithelial skin cells, whereas fibroblasts are responsible for synthesizing fibers and maintaining the extracellular matrix of the tissue.
Keraderm was founded in 2012 when the founders began their initial test treatments in various hospitals in Bogota. Thanks to financial support from private investors and various organizations including Corporación Ventures and Colombia Government's Innpulsa, the product has been patented in Colombia and other countries.
Keraderm was selected in 2013 among over 1500 companies worldwide to participate in the MassChallenge Award entrepreneurship contest in Boston, MA. According to Keraderm's founders "Keraderm was one of 10 companies that received $50,000 and the only non-American to win. This gave us the confidence in our project's international potential and gave us great recognition and credibility in Colombia."
The project leader is Dr. Pedro Martinez-Clark, a Colombian-born and Harvard-trained physician with ample experience in medical technology development. Interventional Concepts aids medical innovators to develop their technologies through their pre-clinical and clinical phases, and its mission is to bridge the medical innovation gap between rich countries and Latin America (with special focus in Colombia for human early-stage clinical trials).