Hemostemix Files for Ethics Approval of its Study of Vascular Dementia

Executive Summary

• Hemostemix filed its Institutional Review Board (IRB) application for a Phase 1 trial of ACP‑01 in vascular cognitive impairment and dementia (VCID/VaD).
• The study will evaluate safety, feasibility and early efficacy of intrathecal autologous stem‑cell therapy in 20–100 participants, with optional second dosing.
• Successful IRB approval positions Hemostemix to advance the first autologous intrathecal stem‑cell treatment targeting brain microvascular repair, addressing a major unmet medical need.

Key Details

• Trial Title: Phase 1 Study – Treatment of Vascular Cognitive Impairment and Dementia with Angiogenic Cell Precursors (ACP‑01).
• Objective: Assess safety, feasibility, and preliminary efficacy of intrathecal ACP‑01 in VCID/VaD patients.
• Design: Multi‑center, open‑label, non‑randomized; 20–100 adult participants (age 50‑100); optional second dose at month 3; follow‑up at 3, 6 and 12 months.
• Primary Endpoints: Safety of intrathecal delivery; incidence & tolerability of adverse events.
• Secondary Endpoints: Changes in cognition (MoCA, MCI Screen), quality of life (SF‑36, Barthel Index), EEG‑based Brain Network Analytics, MRI brain perfusion and volume.
• Exploratory Endpoints: Biomarker responses (IL‑6, CRP, neurofilament light chain); dose‑response between one vs. two treatments; correlation of EEG with cognitive improvements.
• Mechanistic Rationale: ACP‑01 expresses CXCR4 for homing to ischemic brain tissue and releases VEGF, angiogenin, IL‑8, promoting angiogenesis, neuroprotection, and NF‑κB activation (critical for synaptic plasticity).
• Delivery Method: Intrathecal lumbar puncture delivering autologous cells directly into cerebrospinal fluid, bypassing the blood‑brain barrier.
• Safety Oversight: Procedures performed by licensed neurosurgeons in outpatient settings; monitored by an independent Data Safety Monitoring Board.
• Leadership Quote: “Filing our vascular dementia Phase 1 protocol represents a major step forward… we have already demonstrated safety and efficacy of ACP‑01 in the heart and limb. This next trial extends our platform to the brain.” – Thomas Smeenk, President & CEO.

Notable Quotes

“We have already demonstrated the safety and efficacy of ACP‑01 in the heart and limb. This next trial extends our platform to the brain where vascular repair may restore blood flow, memory, and cognition itself.” – Thomas Smeenk, President & CEO, Hemostemix.