Quality of Life (QoL)
death, ®, Pain, amputation, ulcer
DISEASE, MINOR, NECROTIZING FASCIITIS, EVENTS, PERIPHERAL ISCHEMIA, ULCER
Total score for QoL showed an increase over the study period of 12 months. The mean (SD) total score for quality of life increased from 2.39 (0.712) at baseline to 3.77 (1.315) at 1 month, 4.40 (0.873) at 3 months, 4.92 (1.185) at 6 months and 5.63 (1.044) at 12 months which were statistically significant (Mean and percentage change from baseline in RPS, ulcer size, ASP, ABPI, TWD and QoLRPS: Rest Pain Score; ASP: Ankle Systolic Pressure; ABPI: Ankle–Brachial Pressure Index; TWD: Total Walking Distance; and QoL: Quality of LifeChange in efficacy parameters at 12 months compared to baseline of the subjects participated in the studyRest Pain score measured with the help of visual analogue scale; TWD: total walking distance; and ABPI: ankle–brachial pressure indexOf the total of 24 patients dosed, 22 patients completed the studyPatient No. S012 was lost to follow-up after completion of Visit 5. Patient No. S005 discontinued from the study after completion of Visit 6For subjects S016, S017, S018, S019 and S022 virtual visit (telephonic) was performed for Visit 7 (1 year)Neither death nor life-threatening AEs were observed during the 12-month follow-up after stempeucel® therapy. Two serious AEs (necrotizing fasciitis and peripheral ischemia) were observed which were unrelated to the study drug. A total of 8 TEAEs were reported by 6 (25%) out of 24 patients in the study. Majority of the AEs were mild (4 events), 2 events were moderate, and 2 events were severe. All the AEs were evaluated and considered as unrelated to the study drug as the adverse experience being an expected symptom of disease under study or expected outcome of a previously existing or concurrent disease or concomitant medication or procedure as per the treating physician.None of the patients underwent major amputation during the study; however, one patient required minor amputation at 6 months. There were no clinically significant abnormalities during laboratory assessments, physical examination and vital signs recordings during the study.