Ireland’s first human stem cell trial using lab-grown cells is due to get underway in Galway in the new year following approval from the medicines watchdog.
The trial will involve extracting adult mesenchymal stem cells (MSC) from the bone marrow of patients with a condition known as critical limb ischemia (CLI) — a severe blockage of the arteries resulting in marked reduction in blood flow to the extremities.
Reduction in blood flow to the legs puts patients at risk of gangrene, ulceration, and amputation, and the Galway trial will look at the use of MSCs to grow new stems cells which will then be injected back into the patient’s leg with the hope of growing new blood cells and improving circulation.
The harvested stem cells will be grown to much greater quantities in a highly specialised lab before being injected back into the patient’s leg.
Tim O’Brien, director of the Galway-based Regenerative Medicine Institute, said their research was focused on whether MSC therapy could improve blood flow to the legs in patients with CLI — a condition common in diabetics — and therefore avoid the need for amputation. The trial is aimed predominantly at testing the safety and feasibility of what is very much an experimental therapy, Prof O’Brien said.
“We will be doing a dose escalation study, with some patients given a small dose, others a medium dose and the remainder a high dose,” he said. “We want to try and establish how many cells do you need to give a patient.”
The study, the first in humans in Ireland, will be a year-long study involving nine patients. Prof O’Brien said they would not be advertising for participants, but rather would let clinicians know and await referrals of suitable patients.
In the meantime, they would be preparing the custom-built facility where the cells are grown, at the Centre for Cell Manufacturing Ireland in NUI Galway, the first such facility in Ireland to receive a licence from the Health Products Regulatory Authority.
Prof O’Brien said MSCs “have a lot of properties that may make them useful in treating a wide variety of disease” because of their reparative and regenerative qualities.
Prof O’Brien delivered a talk yesterday on the Therapeutic Potential of MSCs in Diabetic Complications on the second day of a two-day international stem cell conference at NUI Galway.
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