A pilot study of clinical cell therapy for patients with vascular dementia

Abstract

Vascular dementia (VD) is a series of clinical and neurophysiological manifestations caused by cerebrovascular disease. As the human lifespan increases, the number of people affected by age-related dementia is growing at an alarming pace, but no proved therapeutic methods can stop it from getting worse.

To investigate the neurorestorative effects of injecting olfactory ensheathing cells (OECs), Schwann cells (SCs), and olfactory receptor neurons (ORNs) into olfactory sub-mucosa in VD patients.

A pilot study of double-blind randomized controlled cell therapies was conducted in VD patients (n = 5). Cells were injected into the patients’ olfactory sub-mucosa. Two patients received OEC treatment, one received SC treatment, one ORN treatment, and one OEC combined with ORN. Mental state and cognitive function were observed before treatment and 1, 3, 6, and 12 months after treatment. magnetic resonance imaging (MRI) or computed tomography (CT) was performed before treatment and 12 months after treatment.

The directional function score on the Mini-Mental Status Examination (MMSE) in the patient who received SC treatment had increased slightly 1 and 3 months after treatment. The scores for orientation, attention, delayed verbal recall, and repetition increased in the ORN group patient 1 month after treatment. The orientation and repetition scores of the ORN group patient continued to increase 3 months after treatment. The scores for attention, delayed verbal recall, and phase 3 command decreased in the OEC and the OEC + ORN group patients after treatment assessment Scores on the Montreal Cognitive Assessment (MoCA) and Clinical Dementia Rating (CDR) scale also improved in the ORN group patient. Clinical and MRI or CT examinations did not find any side effects from the cell therapy or transplanting procedure.

All of the cell transplantations were found to be safe. ORN was shown to be a promising therapy for VD patients. Phase II clinical trials of ORN, SC, and OEC therapy are required to verify their effects on VD symptoms, especially ORNs.