Breathing pattern in a phase I clinical trial of intraspinal injection of autologous bone marrow mononuclear cells in patients with amyotrophic lateral sclerosis

• It is a phase I clinical trial on amyotrophic lateral sclerosis that provides research in the field of security beyond the parameters of spirometry or usual scales.
• If the patients diagnosed with ALS, spinal onset, and duration of disease <36 months have FVC > 50% of predicted, and sleep time oxygen saturation below 90% (T90) ≤2% during 6 months, it is likely that they have stability in breathing pattern 12 months after.
• If the patients diagnosed with ALS, spinal onset, and duration of disease <36 months have FVC > 50% of predicted, and sleep time oxygen saturation below 90% (T90) ≤2% during 6 months, it is likely that they have REM sleep preserved 12 months after.
• The spinal injection of of autologous bone marrow mononuclear cells in patients with amyotrophic lateral sclerosis is safe and it is possible in ALS patients without worsening the disease.

The safety of autologous bone marrow mononuclear cells (ABMNC) intraspinal infusion in amyotrophic lateral sclerosis (ALS) patients was evaluated considering breathing and sleep patterns. Patients between 20 and 65 years old were eligible if they had definite ALS, spinal onset, a disease duration between 6 and 36 months, FVC > 50%, and a below 90% oxygen saturation (T90) <2% of sleep time. The transplant was performed 6 months after enrollment. ABMNC were infused at thoracic 3–4 level. Eleven patients were included. The REM sleep decreased slightly one year after the cell transplant but not significantly. There were no differences in apnea–hipopnea index, mean oxygen saturation and nadir desaturation evolution. An increase of T90 was observed 180 and 360 days after injection (2.95 ± 1.51% and 4.30 ± 4.10% respectively), although it was not statistically significant. The central drive determined by occlusion pressure (P01) and inspiratory flow showed non-significant differences after one year. Intramedullary injection of ABMNC did not worsen the cortico medullar diaphragmatic pathways.