Announced details
Cell therapy for children with chronic-phase cerebral palsy caused by perinatal hypoxic-ischemic encephalopathy
The GMFM-66 score increased by an average of 3.2 points at 12 weeks after administration, ultimately increasing by an average of 4.5 points. The average GMFM improvement rate (GMFMER) was 19.7, compared with 6.0 for other previously reported stem cell therapies.
The clinical study involved 3 children aged 6–11 (time point and number of subjects).
The company is involved in the clinical study led by Nagoya University. The company also conducts joint research with Nagoya University.
University. Details of its location, representative, capital, year of establishment and business activities are Not disclosed.
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
Preprint submitted and published by Nagoya University before peer review (Research Square, https://www.researchsquare.com/article/rs-11215315/v1)
| Item | Details |
|---|---|
| Names of Products / Services Covered | SQ-SHED, SHED (stem cells from human exfoliated deciduous teeth) |
| Counterparty | Nagoya University |
| Counterparty overview | University. Details of its location, representative, capital, year of establishment and business activities are Not disclosed. |
| Relationship with the Company | The company is involved in the clinical study led by Nagoya University. The company also conducts joint research with Nagoya University. |
| Applicable area | Cell therapy for children with chronic-phase cerebral palsy caused by perinatal hypoxic-ischemic encephalopathy |
| Quantitative Effects | The GMFM-66 score increased by an average of 3.2 points at 12 weeks after administration, ultimately increasing by an average of 4.5 points. The average GMFM improvement rate (GMFMER) was 19.7, compared with 6.0 for other previously reported stem cell therapies. |
| Usage history | The clinical study involved 3 children aged 6–11 (time point and number of subjects). |
| Source | Preprint submitted and published by Nagoya University before peer review (Research Square, https://www.researchsquare.com/article/rs-11215315/v1) |
Items this document does not state (10)
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.Evaluations through 52 weeks after SHED administration were completed for all 3 cases, and Nagoya University published a preprint summarizing the final analysis results. The content of the preprint may be revised or changed through peer review and other processes, and efficacy requires further validation.