Kangstem Biotech Rethinks Strategy with New Stem Cell Drug against Atopic Dermatitis
Taking advantage of its pluripotency, researchers have made stem cells into practical treatments since its discovery. Either obtained from bone marrow or the umbilical cord, stem cells could be induced to differentiate into almost any sort of cells, and thus be applied to cure numerous diseases.
Stem Cell Drugs
With the recent advances in research and technology, employing stem cells to treat patients has become possible but it is still expensive. The most common and compatible cell type used is mesenchymal stem cells which could be derived either autologous or heterologous from the bone marrow, adipose tissue, umbilical cord tissue, umbilical cord blood, and placenta. With high purity and intricate induction, stem cells could be made into a universal drug to treat people with specific diseases, instead of complicated transplantation that serves a single patient at a time. This broadened the whole new field of regenerative medicine. The first off-the-shelf stem cell drug was made in 2012 to treat graft versus host disease (GVHD), after which treatments for 100 more diseases with stem cells followed suit. Korea has ranked first in Asia followed by Japan in the number of stem cell drugs approved so far.
Kangstem biotech was founded by Kyung-Sun Kang in 2010. Its mission is to save patients with the mighty power of stem cells. The research group of Kangstem biotech worked together with the Institute for Stem Cell & Regenerative Medicine in developing fundamental regenerative medicines. The company has developed treatments for Atopic dermatitis, Rheumatoid arthritis, Crohn’s disease, which are currently undergoing clinical trials for approval.
Atopic dermatitis is a condition that predominantly affects children and is characterized by eczema that makes the skin red and itchy. Furestem-AD® is one of the drugs generated by Kangstem biotech from umbilical stem cells to rescue people from Atopic dermatitis. However, the results of the phase III trial didn’t meet the requirements with only 21 patients out of 66 achieving EASI-50 (an index referring to the percentage of patients whose eczema area shrank by more than 50 percent, compared to the baseline), as opposed to 22 people out of the 81 who took the placebo pills. The company learned from the failure and adjusted the clinical protocol according to its findings. The drugs taken together by the patients that were not initially banned from the protocol seemed to affect the performance of the treatment. And also the time period between drug production and eventual delivery caused a significant difference.
The phase III trial would be re-applied with a modified new protocol. With a frozen preparation technique and minimal time between drug-production and delivery, the drugs would be taken together by the testers who shall be re-listed. “We hope to finish these works and apply for domestic approval before the end of 2020 so that further approval in Europe and the transition of the technique which we have been organizing since last year could be on time.” said the chief representative of Kangstem biotech.
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