Treating Acute Ischemic Stroke with Dental Pulp Stem Cells (DPSCs)

ABSTRACT

Randomised Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of JTR-161, Allogeneic Human Dental Pulp Stem Cells, in Patients With Acute Ischaemic stRoke (J-REPAIR).
BMJ Open. 2022;12:e054269. doi: 10.1136/bmjopen-2021-054269.

Suda S, Nito C, Ihara M, Iguchi Y, Urabe T, Matsumaru Y, Sakai N; J-REPAIR Trial Group.

Author information:
1.Department of Neurological Science, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
2.Department of Neurology, Nippon Medical School Chiba Hokusoh Hospital, Chiba, Japan.
3.National Cerebral and Cardiovascular Center, Osaka, Japan.
4.Juntendo University Graduate School of Medicine, Tokyo, Japan.
5.Department of Neurology, Jikei University School of Medicine, Tokyo, Japan.
6.Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
7.Department of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.

BACKGROUND: Acute ischemic stroke is caused by an interruption of blood flow to the brain, resulting in neuronal injury and long-term neurological disability. Although treatments such as thrombolysis and mechanical thrombectomy can restore blood flow, many patients remain ineligible or continue to experience significant disability. Dental pulp stem cells (DPSCs) possess neuroprotective, immunomodulatory, angiogenic, and regenerative properties that may reduce brain injury and promote neurological recovery after stroke.

METHODS: The J-REPAIR trial is a multicenter, randomized, placebo-controlled Phase I/II clinical study evaluating JTR-161, an investigational product composed of allogeneic human dental pulp stem cells. Patients with acute ischemic stroke are treated within 48 hours of symptom onset and randomly assigned to receive either a single intravenous infusion of JTR-161 or placebo. The study evaluates safety, neurological recovery, functional independence, and clinical outcomes using standardized stroke assessment scales.

RESULTS: The study protocol was designed to determine whether intravenous administration of allogeneic dental pulp stem cells is safe and whether treatment improves neurological and functional recovery compared with placebo. At the time of publication, patient enrollment and follow-up were ongoing, and efficacy results had not yet been reported.

CONCLUSIONS: The J-REPAIR trial represents one of the first randomized, placebo-controlled multicenter clinical studies evaluating allogeneic dental pulp stem cells for acute ischemic stroke. If successful, this therapy could provide a novel regenerative treatment capable of improving neurological recovery and expanding therapeutic options for stroke patients.

PMID: 35613802
PMCID: PMC9125710
DOI: 10.1136/bmjopen-2021-054269