R-Bio’s VASCOSTEM has been registered with KFDA as the Orphan Drug in Development Phase.
- Adipose-derived stem cells enhance the survival of fat grafted into the face during the treatment of Parry-Romberg disease that causes severe facial deformity
The stem cell treatment VASCOSTEM has been registered as the Orphan Drug in Development Phase.
On February 10th, 2017 the Biostar Stem Cell Research Centre (CEO – Ra Jeong Chan), jointly run by Nature Cell and R-Bio, announced the registration of its VASCOSTEM as the “Orphan Drug in Development Phase” for treatment of Parry-Romberg disease with Korean Food & Drug Administration (KFDA).
VASCOSTEM has been registered with KFDA following the registration of a similar orphan drug for treatment of a rare Buerger’s Disease. On December 14, 2016 the Biostar Stem Cell Research Centre applied to KFDA for registration as an orphan drug at the recommendation of the Korean Society of Plastic and Reconstructive Surgeons, and the registration was approved by KFDA on February 9, 2017.
Parry-Romberg disease is a rare condition that results in progressive hemifacial atrophy, involving the skin, dermis, subcutaneous fat, muscle, and, finally, cartilage and bone, causing severe facial deformity. To date, patients with Parry-Romberg disease have been mostly treated with fat grafts or microvascular free flaps. These techniques have certain limitations when used to treat patients with moderate-to-severe Romberg disease because absorption of grafted fat is rather extensive ie 2-3 months.
To overcome this limitation, the Biostar Stem Cell Research Centre carried out a clinical trial for Romberg disease at the Asan Medical Center in Seoul with the approval from KFDA in 2008. The patients with a moderate-to-severe atrophy who were given microfat grafting simultaneously with injection of cultured augmented adipose-derived stem cells. The survival rate of injected microfat lobules was significantly higher, such outcomes were not achieved in patients who received conventional microfat grafting alone. The clinical trial result was officially published in a global academic journal Annals of Plastic Surgery in September 2012.
The Biostar Stem Cell Research Centre is planning to start a commercial clinical trial in the second half of 2017 to further corroborate the effectiveness and safety of VASCOSTEM. The trial to be completed by the end of 2018, and it will be followed by application for a license.