Announced details
Treatment of children with cerebral palsy; research and development of regenerative medicine products
No adverse events were observed in any of the 3 cases through 52 weeks after administration.
Administered to all 3 cases
S-Quatre Co., Ltd. is conducting the clinical study jointly with Nagoya University. S-Quatre is a group company of キッズウェル・バイオ.
The university leading the clinical study. Other information, including its location, representative, capital, year of establishment and business activities, is not disclosed.
An important milestone supporting the planned clinical trial of the same SQ-SHED product. The specific financial impact is not disclosed.
The company does not address Contract Value / Offering price.
Independent Safety Evaluation Committee
| Item | Details |
|---|---|
| Names of Products / Services Covered | SQ-SHED (Stem cells from Human Exfoliated Deciduous teeth) / autologous dental pulp stem cells from deciduous teeth |
| Counterparty | Nagoya University |
| Counterparty overview | The university leading the clinical study. Other information, including its location, representative, capital, year of establishment and business activities, is not disclosed. |
| Relationship with the Company | S-Quatre Co., Ltd. is conducting the clinical study jointly with Nagoya University. S-Quatre is a group company of キッズウェル・バイオ. |
| Applicable area | Treatment of children with cerebral palsy; research and development of regenerative medicine products |
| Quantitative Effects | No adverse events were observed in any of the 3 cases through 52 weeks after administration. |
| Usage history | Administered to all 3 cases |
| Impact on Business Performance | An important milestone supporting the planned clinical trial of the same SQ-SHED product. The specific financial impact is not disclosed. |
| Source | Independent Safety Evaluation Committee |
Items this document does not state (9)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Following the completion of the observation period for all 3 cases, the safety assessment found no adverse events associated with intravenous administration of autologous dental pulp stem cells from deciduous teeth.