Adipose derived stem cells as local treatment of ulcerative colitis

Phase 1

Active, not recruiting

• Conditions: lcerative colitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2022-002325-99-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-15
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Inklusionskriterier
a)Alder 18-70 år
b)Kendt colitis ulcerosa med udbredning begrænset til venstre side af tyktarmen
c)Mild-moderat aktivitet i CU vurderet ved komplet Mayoscore > 2 og < 10
d)Taler og forstår dansk
e)Fuldt informeret samtykke

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Eksklusionskriterier
a)Svær sygdomsaktivitet vurderet på Mayoscore (score > 10)
b)Akut svær colitis ifølge Truelove-Witts kriterier
c)Sygdomsudbredning proksimalt for venstre fleksur (ekstensiv colitis)
d)Aktiv malign sygdom
e)Graviditet (kontrolleres med graviditetstest (urin-HCG), hvis fertil kvinde)
f)Ryger (defineret som rygestop< 12uger)
g) Penicillinallergiker (slutproduktet indeholder spor af penicillin)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified