medwireNews: Evidence supporting the safety of spinal cord transplantation of human stem cells in patients with amyotrophic lateral sclerosis (ALS) could pave the way for efficacy trials.
The class IV evidence comes from a trial of 15 ALS patients from three academic centres who all received bilateral injections of human spinal cord-derived neural stem cells to the cervical spinal cord (C3–C5), while one group also received injections to the lumbar cord (L2–L4).
The numbers of injections ranged from 10 to 40 and the number of cells injected from 2 million to 16 million.
The majority of patients had an uneventful surgical course and were discharged after 4 days. Unwanted effects were generally related to surgery, including incisional pain and transient paraesthesias, or the immunosuppressive drugs used.
Two patients developed serious complications related to treatment – acute postoperative deterioration in neurological function and central pain syndrome. But lead author Jonathan Glass (Emory University School of Medicine, Atlanta, Georgia, USA) said in a press statement that “the level of acceptable risk for treating patients with ALS, where the prognosis is poor and treatments are limited, is arguably higher than that for more benign disorders.”
The researchers point out in Neurology that they “succeeded in moving this complex procedure from a single surgical center to 3 centers, demonstrating that this therapeutic approach is amenable to scaling up for the treatment of larger numbers of participants in a multicenter trial of efficacy.”
By Lucy Piper
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