GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage

This study has been terminated.
(Need for improvement of study medication. Safety data collected sufficient. No further gain in knowledge expected.)
Sponsor:
Information provided by:
CellMed AG, a subsidiary of BTG plc.
ClinicalTrials.gov Identifier:
NCT01298830
First received: February 15, 2011
Last updated: March 25, 2013
Last verified: March 2013

February 15, 2011
March 25, 2013
October 2008
June 2011   (final data collection date for primary outcome measure)
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01298830 on ClinicalTrials.gov Archive Site
Neurological conditions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage
GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage

The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Intracerebral Hemorrhage (ICH)
Drug: GLP-1 CellBeads
GLP-1 CellBeads are alginate microcapsules containing allogenic mesenchymal cells, transfected to secrete Glucagon like peptide-1. By implantation into brain tissue cavity after surgical evacuation of the hematoma, a volume of 500μl GLP-1 CellBeads which equals approximately 2330 GLP-1 CellBeads resulting in a total number of approximately 7.8 million cells is administered to the patient. The cells are removed by second surgery after a 14 days treatment period.
Experimental: GLP-1 CellBeads
Intervention: Drug: GLP-1 CellBeads
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage in conjunction with ICH by cranial computed tomography (CCT) or Magnetic Resonance Tomography (MRT)
  • Patients who need by judgement of a clinical neurologist or neurosurgeon surgical removal of the blood clot due to its space-occupying effects
  • Age greater or equal 18 years for men
  • Age greater or equal 18 years for women if confirmed infertility (e.g. hysterectomy or surgical sterilisation at least 3 months before study start)
  • For all other women age greater or equal 50 years with last menstrual bleeding at least one year before study start
  • Minimum hematoma diameter of 2 cm as measured in baseline CCT or MRT
  • Signed, written informed consent of patient or consent/assertion from the patient's legally acceptable representative/affiliated if the patient is unable to provide informed consent

Exclusion Criteria:

  • Participation in any other clinical trial within the past 3 months or ongoing
  • Occurrence of inconsistency with initial diagnosis at baseline during surgery of the patient leading to unfulfilled inclusion criterion Hemorrhage secondary to tumour or trauma
  • Patients with a cerebellar hemorrhage or extension of a supratentorial hemorrhage into the brainstem
  • Patients with severe pre-existing physical or mental disability or severe comorbidity that interferes with the assessment of outcome
  • Allergy to contrast media (MRT)
  • Acute infection
  • Muscular, neurological, or vascular insufficiency of the respective tissue
  • Polypropylene incompatibility
  • Acute immunosuppressive medication
  • Patient after organ transplantation
  • Patient with immune depression
  • Patients with a high probability of spontaneous recovery or showing rapidly improving signs
  • Patients with extensive intracranial hemorrhages or with deep hemispheric localisation of the clots
  • Patients whose diagnosis of ICH is uncertain
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01298830
CM GLP-1/01, 2007-004516-31
Yes
Dr. med. Peter Geigle / CEO, CellMed AG
CellMed AG, a subsidiary of BTG plc.
Not Provided
Study Chair: Thomas Brinker, Prof. Dr.med. International Neuroscience Institute Hanover
CellMed AG, a subsidiary of BTG plc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP