01
Advanced Regenerative Medicine Therapeutics (RMAT)
designation approval
← 10 major life businesses
Research toward life,
STEM CELL THERAPEUTICS
01 / Stem cell therapy
Research toward life,
Three remedies.
Joint Stem · Astro Stem · Bath Costume Stem
business talk ↓
US edition · product referenceFDA letter headed “Grant Regenerative Medicine Advanced Therapy Designation,” dated October 22, 2025, reference IND 15489. The document is already in English; this designation is not a marketing approval.
Joint stem / JOINTSTEM
Joint Stem, the world's first stem cell treatment for knee osteoarthritis, approved by three major U.S. companies
US edition · product referenceFDA letter headed “Grant Breakthrough Therapy Designation,” dated December 16, 2024, reference IND 15489. The document text is already in English. A designation is not a product marketing approval.
02
Breakthrough Therapeutics (BT)
designation approval
US edition · product referenceFDA letter headed “Acknowledge Treatment Protocol,” dated June 9, 2025, reference IND 15489/85. The document is already in English and relates to a specific investigational protocol; it must not be presented as general marketing approval.
03
Compassionate Use Program (EAP)
designation approval
Astrostem / ASTROSTEM
Treatment of neurological diseases through repeated intravenous administration of autologous adipose-derived mesenchymal stem cells
ALZHEIMER’S DISEASE
Alzheimer's disease
Phase 1/2 clinical trials completed in the US → Preparation for phase 2b clinical trials
AUTISM SPECTRUM DISORDER
autism spectrum disorder
Phase 1 IND approval for US adult ASD clinical trial
VASCOSTEM
Severe limb ischemia stem cell treatment
01
research subject
Pain at rest, ulceration, necrosis, hypoperfusion (insufficient blood flow)
02
Key verification results
After intramuscular administration of stem cells, it was confirmed that new microvascular networks (collateral vessels) were significantly formed around the occluded blood vessels, thereby restoring blood flow.
03
Changes in Research and Treatment
Salvage of limbs, formation of new blood vessels, improvement of pain and ulcers