A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITIS

• Register: EUCTR
• Last refreshed on: 21 January 2013
• Main ID: EUCTR2010-023798-20-ES
• Date of registration: 10/05/2012
• Prospective Registration: Yes
• Primary sponsor: Fundacion para la Investigacion Biomedica Hospital Universitario La Paz
• Public title: A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITIS
• Scientific title: A PHASE I/IIA CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (ASC) ON INDUCTION TO REMISSION IN ULCERATIVE COLITIS - ALOASCU
• Date of first enrolment: 29/11/2012
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023798-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Spain

Contacts

• Name: Ensayo Clinico ALOASCU
• Affiliation: Hospital Universitario La Paz

• Name: Ensayo Clinico ALOASCU
• Affiliation: Hospital Universitario La Paz

Key inclusion & exclusion criteria

Inclusion criteria:
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 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: ASC
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: adipose tissue-derived mesenchymal stem cells
Other descriptive name: aloASC
Concentration unit: million organisms/ml million organisms/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective:

Secondary Objective:

Primary end point(s):

Secondary ID(s)

HLPDIG-2010-01

Source(s) of Monetary Support

Ministry of Health and Social Policy