Olfactory ensheathing cells in chronic ischemic stroke: A phase 2, double-blind, randomized, controlled trial

Abstract

Olfactory ensheathing cells (OECs) have shown promising results for patients with neurologic diseases in non-double-blind, placebo control studies. Thirty patients with a unilateral ischemic stroke of more than a year were enrolled in a phase 2, multicenter, randomized, double-blind, and placebo-controlled cell therapy trial with a subsequent 12-month follow-up. The primary therapeutic objective has shown that after 12 months, there were significant differences in National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and Barthel Index (BI) assessment scores among the OEC group, Schwann cell group and placebo medium group at one-year follow-up. The second therapeutic objective found that there were significant differences in NIHSS, mRS, and BI assessment scores when comparing the endpoint data with the baseline data in the OEC group. There was neither hypersensitivity reaction nor adverse event. The results of this multicenter, randomized, double-blind, and placebo-controlled study indicate that injecting OECs into the olfactory sub-mucosa have neurorestorative effects, which can improve the quality of life for patients with chronic ischemic strokes without serious side effects.

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

“…ORN and SC preparation was the same as that in our previous published paper [14]. ORN preparation and identification met the professional quality control standards of Chinese Association of Neurorestoratology (CANR; Preparatory) [15].…”

“…Figure 1 shows the cell injection procedure. The procedure was the same as that used in our previous published paper [14]. Each participant was injected with 0.3 mL medium on each side of the septum with 5 × 10 6 OECs, or 5 × 10 6 SCs, or 5 × 10 6 ORNs, or 2.5 × 10 6 OECs + 2.5 × 10 6 ORNs.…”

Technological Advances of 3D Scaffold-Based Stem Cell/Exosome Therapy in Tissues and Organs

“…For stroke treatment, Moshayedi et al (2016) reported that as a platform to promote the adhesion of structural motifs and release of growth factors, an HA-based self-polymerizing hydrogel promoted differential maturation of NPCs in the stroke cavity and improved the survival rate of NPCs, which can be tracked by magnetic resonance imaging ( Guo et al, 2019 ; Wang et al, 2020 ).…”

Clinical diagnostic and therapeutic guidelines of stroke neurorestoration (2020 China version)

“…Ischemic stroke and hemorrhagic stroke in this phase are treated with the same neurorestorative therapy. The main objective is to restore the damaged neurological function and/or structure, reduce the degree of disability [52], and improve the quality of life.…”