Stemirac is developed for 1 unique indication across 1 therapeutic area.
Therapeutic Area
Condition
Phase
Injury, poisoning and procedural complications
Spinal cord injury
✓ Approved
Related Research Articles
PubMedThe spine journal : official journal of the North American Spine Society2026-01-10
Stem cell therapy for spinal cord injury: lessons from Japan's experiment in regulatory deregulation.
Kawaguchi Hiroshi H
Stem cell-based therapies for spinal cord injury (SCI) have generated substantial global interest; however, no regenerative treatment has yet demonstrated sufficient efficacy to achieve full regulatory approval in major jurisdictions. In Japan, an expedited regulatory framework enabled the conditional approval of Stemirac, an autologous mesenchymal stem cell therapy for SCI, based on limited and uncontrolled clinical evidence. This Perspective examines the scientific, methodological, and ethical implications of that decision. Focusing on trial design, outcome assessment, extensive public and media attention during the confirmatory trial period, and downstream societal consequences, we explore how premature commercialization under public reimbursement may compromise scientific rigor and erode public trust. The Stemirac case offers important lessons for regulators, clinicians, and researchers worldwide, underscoring the need to balance rapid patient access with robust evidentiary standards in the development of regenerative therapies for SCI.
Stem cell therapies for spinal cord injury in humans: A review of recent clinical research.
Sugai Keiko K, Nakamura Masaya M, Okano Hideyuki H, Nagoshi Narihito N
Recently, cell transplantation has emerged as a promising treatment for spinal cord injury (SCI). Over the past decade, numerous clinical studies of SCI have been conducted using various types of cells, including fetal neural stem/progenitor cells (NS/PCs), pluripotent stem cell-derived NS/PCs, mesenchymal stem/stromal cells (MSCs), olfactory ensheathing cells, and Schwann cells. Promising results have been reported for patients with subacute SCI, especially in studies involving MSCs, such as those conducted with Stemirac, although no universally recognized breakthroughs have been achieved. Allogenic NS/PCs may offer advantages over autologous MSCs because they have the potential for cell engraftment within the spinal cord and can be prepared in advance, facilitating their administration during the hyperacute phase. Recent advances achieved with induced pluripotent stem cells indicate their promise potential to be used in future therapies. This review provides an overview of recent clinical studies and discusses potential advancements anticipated in the future.
PubMedBrain and nerve = Shinkei kenkyu no shinpo2023-05-17
[Drugs under Development (Neurosurgery)].
Ueba Tetsuya T
In this section, new arsenals for neurological treatment based on an open source are introduced. "Delytact" and "Stemirac" are discussed in this section. These two new arsenals have been accepted as cell and gene therapy products by the Ministry of Health, Labor, and Welfare. "Delytact" is a viral-gene therapy that targets malignant brain tumors, such as malignant gliomas, while "Stemirac" targets against spinal contusion via self-mesenchymal implantation. Both are permitted clinical arsenals in Japan.