S.BIOMEDICS

Treatment of Subacute Spinal Cord Injury TED-N Embryonic Stem Cell-derived PSA-NCAM positive Neural Precursor Cells

Spinal Cord Injury: As an irreversible damage to intraspinal nerve cells, it causes permanent disability.

Cause: Primary: Damage to intraspinal nerve cells due to internal/external factors such as traffic accident or fall
Secondary: Accompanied by serious disability due to inflammation, apoptosis, etc.
Symptom: Fever due to abnormal regulation of body temperature
Motor and sensory disorders, urination disorders, etc. due to paralysis below the injured site

Basic Research	Non-clinical	Phase 1	Phase 2	Phase 3	Approval
Phase 1/2a

OUTLINE

Therapy: Inject into damaged spinal cord nerve cell

Technology: Embryonic stem cells using TED technology (using DM/SB)

TED

Cell sorting using PSA-NCAM marker

PSA-NCAM sorting

DATA

Anti-Inflammation

The anti-inflammation effect was confirmed as one of the mechanisms of action (MoA). Observation of intraspinal microglia (Iba-1) and microglia (ED1) activated by inflammation after the transplant of TED-N in an animal model with spinal cord injury showed that the rate (%) of microglia (ED1) activated by inflammation decreased in the group with TED-N transplant compared to the control group.

	lba-1	ED1	DAPI	Merged
Control
TED-N

p < 0.0004

Angiogenesis

The angiogenesis effect was confirmed as one of the mechanisms of action (MoA). Observation of angiogenesis factor (Alpha-SMA) after the transplant of TED-N in an animal model with spinal cord injury showed an increase in the group with TED-N transplant compared to the control group.

	Alpha-SMA	DAPI	Merged
Control
TED-N

p < 0.0005

Cell Proliferation

The cell proliferation effect was confirmed as one of the mechanisms of action (MoA). Observation of proliferative cells (BrdU) after the transplant of TED-N in an animal model with spinal cord injury showed an increase in the group with TED-N transplant compared to the control group.

	BrdU	DAPI	Merged
Control
TED-N

p < 0.02

Motor Function Improvement: As a result of evaluating the motor function after the transplantation of TED-N to an model animal with spinal cord injury using BBB score (Basso, Beattie and Bresnahan score), motor function was improved in the group with TED-N transplant compared to the control group.