Safety of Intravenous Administration of Biostar’s Cultured Stem Cells was Proven: No Possibility of Cancer Occurrence from Multiple Infusions

January 9, 2018 PR-M01-18-NI-022

  • For the first time in the world, Dr. JeongChan Ra’s research team in the Biostar Research Institute announced long-term follow-up study results of tumorigenicity of the cultured stem cells infusion
  • The safety was proven as there were no changes in biomarker levels after administering stem cells over 3 years, regardless of the subject’s age or gender
  • The clinical study results were published in the Journal of Clinical Case Reports, an international journal of medicine
 

SEOUL, South Korea — () — A clinical study on safety found that multiple intravenous administrations of cultured human autologous adipose-derived stem cells which were cultured by Biostar Stem Cell Research Institute do not affect the incidence of cancer in human subjects.

Nature Cell(KOSDAQ: 007390), a high-tech Bio company and Biostar Stem Cell Research Institute(Chairman JeongChan Ra) announced on the 5th January that there was no association between incidence of cancer and the intravenous administration of autologous adipose-derived stem cells, cultured by Biostar Stem Cell Research Institute. This study is the first ever in the world to have clinically tracked over a long term any tumorigenicity after multiple intravenous administrations of cultured human stem cells.

The paper was published in the Journal of Clinical Case Reports, an international journal of medicine, under the title, ‘Effect of the Multiple Intravenous Administration of Cultured Human Autologous Adipose-Derived Stem Cells on Tumor Biomarker Levels’.

Dr. JeongChan Ra and his research team at Biostar Stem Cell Research Institute measured the changes in biomarkers for tumors in the blood of the subject that had undergone the intravenous administration of cultured human autologous adipose-derived stem cells and verified that the administration had no correlation with cancer occurrence. In particular, there was no statistically significant difference in the tumor biomarker levels irrespective gender and age.

The Dr. Ra’s research team has examined 462 patients who were administered more than 1 billion cultured autologous adipose-derived stem cells multiple times from 2010 to 2013 at medical institutions in Japan. The stem cells were cultured using the technology of Biostar Stem Cell Research Institute. The tumor biomarker diagnostic samples were collected and stored before the initial stem cell administration (2010~2013) and after the administration of stem cells (2016). They conducted a world-first retrospective study of the changes in eight types of tumor biomarker over three to six years.

The test items were a total of eight, namely biomarkers for liver cancer (AFP), colorectal cancer (CEA), pancreatic cancer (CA19-9), stomach cancer (CA72-4), prostate cancer (Total PSA, PSA-f/T), breast cancer (CA15-3), and ovarian cancer and endometrial cancer (CA125). Five items of them were selected for males and six of them were selected for females. The result showed that there was no change in tumor biomarkers and all levels were within the normal reference range. In fact, the subjects who had tumor biomarker levels outside the reference range entered the reference range after administration.

Dr. Ra of Biostar Stem Cell Research Institute commented, “We believe that concerns over the intravenous administration of autologous adipose-derived stem cells possibly causing cancer will be dispelled with this study results. We are pleased to announce that the stem cells cultured using our technology is found not to cause any cancer. The result will be submitted as one of safety data for getting approval for treatment of Alzheimer’s disease in Japan.”


Source
Journal of Clinical Case Reports
Effect of the Multiple Intravenous Administration of Cultured Human Autologous Adipose-Derived Stem Cells on Tumor Biomarker Levels
Case Report: Ra et al., J Clin Case Rep 2017, 7: 1040
DOI: 10.4172/2165-7920.10001040


Nature Cell
Nature Cell (KOSDAQ: 007390) is a high-tech bio enterprise that runs Stem Cells business. The company has exclusive rights for business of products developed by Biostar Stem Cell Research Institute. More information about Nature Cell can be found at www.naturecell.co.kr.


Contacts
Nature Cell
Sanghwn Song
Tel: +82 2 6978 9108
Email: shsong@naturecell.co.kr

 

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

Biostar Stem Cell Research Institute

Biostar Stem Cell Research Institute is the adult-derived stem cells research firm. The institute has cutting edge technologies and equipment for stem cell separation, cultivation and storage, and strives to develop technologies for commercialization of JointStem—an autologous stem cell-based medicine for degenerative arthritis patients, AstroStem—treatment of spinal injury patients and Alzheimer's disease, VascoStem—a candidate for a new drug to treat Burger’s disease which causesischaemic necrosis and the Parry Romberg disease which causes anti-facial atrophy.

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