Trial Profile

Phase 1 clinical study of iPSC-derived regenerative cell therapy

Status: Planning

Phase of Trial: Phase I

Latest Information Update: 06 Jun 2025

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At a glance

Drugs IPSC-derived-regenerative-cell-therapy-XellSmart-Biomedical-(Suzhou) (Primary)
Indications Spinal cord injuries
Focus Adverse reactions; Pharmacokinetics

06 Jun 2025 New trial record
25 May 2025 According to XellSmart Biomedical (Suzhou) media release, the study will be led by the Third Affiliated Hospital of Sun Yat-sen University, a nationally recognized leader in spinal cord injury treatment.
25 May 2025 According to XellSmart Biomedical (Suzhou) media release, company announced that XellSmart-developed off-the-shelf allogeneic iPSC-derived subtype-specific neural regenerative cell therapy has received official approval from both China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) for a Phase I clinical trial, to treat spinal cord injury.

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