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

Intracerebral Hemorrhage (ICH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01298830
• Other study ID #: CM GLP-1/01
• Secondary ID: 2007-004516-31
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 15, 2011
• Last updated: March 25, 2013
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2013
• Source: CellMed AG, a subsidiary of BTG plc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage (ICH)

Intervention

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.

Locations

Country	Name	City	State
Germany	Neurochirurgische Klinik der Universität Erlangen-Nürnberg	Erlangen	Bavaria
Germany	International Neuroscience Institute	Hannover	Lower Saxony
Germany	Klinik für Neurochirurgie Medizinische Hochschule Hannover	Hannover	Lower Saxony
Germany	Klinikum Region Hannover Krankenhaus Nordstadt, Klinik für Neurologie	Hannover	Lower Saxony
Germany	Neurochirurgische Klinik und Neurologische Klinik des Universitätsklinikums Heidelberg	Heidelberg	Baden-Württemberg
Germany	Klinik für Neurochirurgie Klinikum Bogenhausen Akademisches Lehrkrankenhaus der Technischen Universität München	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
CellMed AG, a subsidiary of BTG plc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage		6 months	Yes
Secondary	Neurological conditions		6 months	No