WHO ICTRP trial
The aim of this clinical study is to show the clinical efficacy and safety of…
EUCTR2010-021463-32-AT · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2010-021463-32-AT |
|---|---|
| Public title | The aim of this clinical study is to show the clinical efficacy and safety of SMDCs in patients suffering from FI, and to find the optimal cell count for the functional regeneration of the external anal sphincter. |
| Scientific title | Skeletal muscle-derived cell implantation for the treatment of fecal incontinence: a multicenter, randomized, double-blind, placebocontrolled, parallel-group, dose-finding clinical study - STEFFI |
| Primary sponsor | Innovacell Biotechnologie AG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Czech Republic;Slovenia;Austria;Bulgaria;Germany;United Kingdom;Sweden |
| Conditions | Fecal incontinence in female and male patients with external anal sphincter weakness or sphincter damage. MedDRA version: 20.0 Level: LLT Classification code 10016296 Term: Fecal incontinence System Organ Class: 100000167639 ;Therapeutic… |
| Interventions | Product Name: autologous Skeletal Muscle Derived Cells Product Code: aSMDC Pharmaceutical Form: Suspension for injection Current Sponsor code: aSMDC Other descriptive name: autologous Skeletal Muscle Derived Cells Concentration unit: Other… |
| Registration date | Nov 30, 2010 |
| Target size | 252 |
| Secondary IDs | IC-01-02-02-007 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: