Biostar Stem Cell Research Institute submits to KFDA the supplementary documents on ‘Vascostem’, a stem cell treatment for Buerger’s Disease, regarding orphan drug designation

  • 11 KFDA approved ingredients found to be untested on patients with Buerger’s Disease
  • Immediate decision required with national profit and patient health as top priority

Biostar Stem Cell Research Institute, joint operated by Nature Cell and R Bio, announced that on the 18th they have submitted to KFDA the supplementary documents on ‘Vascostem’, a stem cell treatment for Buerger’s Disease.

Eun Chong Ban, the CEO of R Bio(to the right), submitting supplementary documents to KFDA on 18th.

Eun-Chong Ban, the CEO of R Bio(to the right), submitting supplementary documents to KFDA on 18th.

Vascostem was recommended to be designated as an orphan drug at Korea Orphan Drug Center expert meeting and was submitted to KFDA for it, but because there already has been KFDA approved alternatives and improvement in safety and efficacy was considered insignificant according to KFDA, Vascostem was not designated for over a year. However, the supplements submitted seem to have overturned KFDA’s claim by explaining that there was no evidence of the 11 KFDA approved alternatives (i.e. cilastazol, berprost) going through clinical trials either nationally or internationally.

Furthermore, Biostar SCRI reported that they have confirmed through clinical results and over 2 years of tracking results that Vascostem’s improvements in walking distance, pain, and prevention of amputation have been recognized, and most of the tracked respondents completely stopped taking KFDA approved alternatives including painkillers.

“Orphan drug designation program is meant to provide possible treatments faster to patients with incurable rare disease, but KFDA operating differently from its intention saddens me.  KFDA should expunge any misunderstandings and antagonisms and think of national profit and patients’ health as top priority,” said Dr. Jeong-Chan Ra, the director of Biostar Stem Cell Research Institute.

Buerger’s Disease is an occlusive thrombus vasculitis commonly occurred in young men in twenties to forties. It causes the blood vessels of fine arteries to be clogged, which may lead to necrosis or amputation of extremities. Vascostem was developed as the world first stem cell treatment, but while its orphan drug designation has been delayed for more than a year, approval from Japan’s Ministry of Health and Welfare was received within 2 months after submission, and stem cell therapy is now being used on patients from all over the world including Korea and Japan.

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