Scientists at Lineage Cell Therapeutics hope to treat spinal cord injuries with an allogeneic therapy created from oligodendrocyte progenitor cells.
“We manufacture oligodendrocyte progenitor cells and inject them in the area of the injury,” explains CEO Brian Culley. “The cells occupy the cavity—the hole where healthy cells have died off—and then make myelin and secrete neurotrophic factors to aid recovery.”
In a Phase I/IIa trial of 25 patients, this treatment, known as OPC1, caused no serious adverse events and one-third of the patients experienced substantial motor-skill improvements.
From that study, Culley and his colleagues saw a need to improve the scale and purity of the bioprocessing.
“We took an academic, research-grade process and started rebuilding it into something which could be a commercial product available to many patients,” Culley says. “If you make an improvement to an early step and get better yield, then the next step starts off in a better place and so on to completion.”
Overall, the team increased the production of cells by 10–20 times and reduced impurities by 50–75%. Now, says Culley, they have a process that can supply cells for a late-stage clinical trial, and they have the means to scale even higher. Early next year, talks will start with the FDA about a late-stage trial for OPC1.
“Autologous approaches have accomplished much, especially in treating cancer, but in the long run they can’t match the scale and speed of an allogeneic therapy,” Culley continues. “I think allogeneic will be a much more appropriate and economical approach in many settings, especially in large patient populations or urgent conditions.”
Culley’s team is running clinical trials of its technology in cancer, dry age-related macular degeneration, and spinal-cord injuries.
“Overall,” points out Culley, “we’re indifferent to the technology we use. We just want a cell that works safely in the patient, and patients just want safe and effective therapies.”