Clinical Trial of Umbilical Cord Mesenchymal Stem Cells in Subacute Ischemic Stroke

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai IxCell Biotechnology Co., LTD

About this trial

The goal of this clinical trial is to evaluate the efficacy, safety, and pharmacodynamic characteristics of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in adults with ischemic stroke in the anterior circulation during the recovery phase. Researchers will compare hUC-MSCs to a placebo to determine whether hUC-MSCs treatment is effective in treating recovery-phase anterior circulation ischemic stroke.

Eligibility criteria

Qualifiers

Age ≥18 years and ≤70 years, regardless of gender.

14 to 90 days after ischemic stroke.

Clinical diagnosis of anterior circulation ischemic stroke.

National Institutes of Health Stroke Scale (NIHSS) score is 6-20 points (inclusive), with NIHSS motor arm (item 5) or motor leg (item 6) score of 2-4 points, and NIHSS level of consciousness item (1a) score <2 points.

Disqualifiers

People who had a history of epilepsy, dementia, Parkinson's disease, severe depression, or other neurological or psychiatric disorders.

Intracranial hemorrhagic conditions.

Pre-stroke mRS score >1.

Severe cardiovascular disease.

Trial design

Treatments tested in this trial

  • Placebo
  • IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells)

Treatment groups

86 Participants
are divided into 2 treatment groups