It is the first time that scientists have officially published a long-term clinical study showing that there is no meaningful correlation between fat tissue-derived stem cell injections and the onset of cancer, according to the company.
The research paper, titled “Effect of the Multiple Intravenous Administration of Cultured Human Autologous Adipose-Derived Stem Cells on Tumor Biomarker Levels,” has been published in the Journal of Clinical Case Reports.
The data was compiled by Biostar Research Institute, jointly operated by Nature Cell and R Bio, which collected a patient’s blood before and after the patient received an intravenous injection of its adipose tissue-derived stem cell therapy. It then analyzed and compared the blood samples for signs of cancerous tumors.
As a result, it did not discover any statistically meaningful correlations between the two events, the institute said. The findings are expected to help relieve safety concerns that growth factors secreted by stem cells may promote the growth of cancer cells and create a favorable environment for their proliferation, the paper said.
Around 460 Korean patients were injected with Nature Cell’s fat tissue-derived stem cell therapy multiple times, receiving a total of more than 1 billion stem cells via injections into their veins. The injections were administered at medical institutions in Japan from 2010 to 2013.
Patients’ blood samples taken prior to the injections and were compared with those taken several years after they finished receiving the stem cell treatments, in 2016. The retrospective comparisons -- made after a timespan of three to six years depending on the patient -- sought to identify tumor biomarkers for eight types of cancers.
They include liver cancer, colon cancer, gastric cancer, pancreatic cancer, prostate cancer, breast cancer, ovarian cancer and endometrial cancer.
“We expect that the safety concerns partially raised of our stem cell therapies will be eradicated through this clinical research,” said Ra Jeong-chan, CEO of Nature Cell and head of the Biostar Stem Cell Research Institute.
“We are happy to have proven in the least that stem cells engineered with our proprietary technology are safe from cancer risks,” he said.
Nature Cell expects the new data to act as additional evidence in scoring sales approval for its stem cell therapy targeting Alzheimer’s in Japan, which is poised to come in February, the company said.
Stem cells — progenitor cells able to develop into various types of tissue — are perceived as the key to advances in regenerative medicine which helps the body heal itself. Stem cell therapies are engineered by extracting stem cells from a patient’s own tissue, and incubating them.
Seoul-based Nature Cell has developed stem cell therapies targeting osteoarthritis — “Joint Stem” and Alzheimer’s — “Astro Stem” — which have completed phase 2 clinical trials in the US.
The drugmaker has concluded phase 2 trials of “Joint Stem” in Korea, and is working on obtaining conditional sales approval from Korean Ministry of Food and Drug Safety, based on fast-track approval procedures for drugs targeting rare or severe irreversible diseases.
By Sohn Ji-young (email@example.com)