Table 2.
Schedule of enrolment, intervention and assessment
| Study period |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Process | Screening and Enrolment | Allocation | Postallocation period (weeks) |
Follow-up period (months) |
||||||
| Timepoint | −30 days | 0 | 3 h | 1 | 4 | 8 | 4 | 6 | 9 | 12 |
| Enrolment and screening | ||||||||||
| Eligibility screening | X | X | ||||||||
| Informed consent | X | |||||||||
| Medical or drug history | X | |||||||||
| Physical examination/vital signs | X | X | X | X | X | X | X | X | X | |
| Urine β-hCG* | X | X | X | |||||||
| Serological and biochemical tests | X | X | X | X | X | |||||
| Urinalysis | X | X | X | X | X | |||||
| ABO Rh | X | |||||||||
| HBsAg | X | |||||||||
| HCV & HIV | X | |||||||||
| VDRL | X | |||||||||
| Digital rectal examination | X | X | X | X | X | X | X | X | X | X |
| Intervention | ||||||||||
| ALLO-ASC injection† | X | |||||||||
| Assessment | ||||||||||
| Local tolerability | X | X | X | X | X | X | X | X | ||
| Immunological test (CD4/CD8) | X | X | X | |||||||
| Wexner score | X | X | X | X | X | X | X | X | X | |
| Anorectal manometry | X | X | X | X | X | X | X | |||
| Endorectal ultrasonography | X | X | X | |||||||
| Patient satisfaction survey | X | X | X | X | X | X | ||||
| FIQL | X | X | X | X | X | X | X | |||
| Stool diary | X | X | X | X | X | X | X | X | X | |
| Adverse events | X | X | X | X | X | X | X | X | ||
| Concomitant medications | X | X | X | X | X | X | X | X | X | |
*Performed in fertile women.
†In the dose-escalation test, ALLO-ASCs are injected. In the efficacy test, a mixed solution of ALLO-ASCs with fibrin glue is injected in the experimental group.
ALLO-ASC, allogeneic-adipose-derived mesenchymal stem cells; β-hCG, β-human chorionic gonadotropin; HBsAg, HBV surface antigen; HCV, hepatitis C virus; FIQL, Faecal Incontinence Quality of Life Instrument; VDRL, Venereal Disease Research Laboratory.