Clinical Study

Intraspinal Transplantation of the Adipose Tissue-Derived Regenerative Cells in Amyotrophic Lateral Sclerosis in Accordance with the Current Experts’ Recommendations: Choosing Optimal Monitoring Tools

Table 2

Timetable of the adipose-derived regenerative cell (ADRC) isolation and transplantation study.

Action visitV1 screeningV2V3V4V5V6V7

Week−24−12012243648
Permitted delta in weeks to V1+2+2+2+/−2+/−2
Interventions
Intraspinal transplantationX
Intrathecal transplantationXX
Screening assessment
Patient information, informed consentXXXX
Inclusion/exclusion criteriaX
Medical historyXXXXXX
Diagnosis according to EECXXXXXX
Physical and neurological examinationXXXXXXX
EMGX
MUNIXXXXXXXX
Spinal MRI C with contrastX
Spinal MRI Th with contrastXXXX
Spinal MRI S with contrastXXXX
Spinal MRI ThXXX
Spinal MRI LSXXX
SpirometryXXXXXXX
Chest X-rayX
Laboratory studiesXXXX
Muscle strength assessment
MRCXXXXXXX
HHDXXXXXXX
Functional assessment
ALSFRS RXXXXXXX
2MWT (with concomitant BS)XXXXXXX
5STSXXXXXXX
TUGXXXXXXX
TCTXXXXXXX
FATXXXXXXX
Other examinations
FSSXXXXXXX
MASXXXXXXX
Psychological assessment
ADI-12XXXX
ACSAXXXX

MUNIX: motor unit number index (MUNIX). Examination performer 48 h after the ARDC transplantation. MRC: Manual Muscle Test Medical Research Council; HHD: handheld dynamometer (HHD); ALSFRS R: amyotrophic lateral sclerosis functional rating scale-revised; 2MWT: two-minute walk test; BS: Borg scale; 5STS: Five Times Sit to Stand test; TUG: Timed Up and Go; FAT: Frenchay Arm Test; TCT: Trunk Control Test; MAS: Modified Ashworth Scale; FSS: Fatigue Severity Scale; ADI-12: ALS Depression Inventory; ACSA: Anamnestic Comparative Self-Assessment.