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
  Purpose

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


Condition Intervention Phase
Intracerebral Hemorrhage (ICH)
Drug: GLP-1 CellBeads
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage

Resource links provided by NLM:


Further study details as provided by CellMed AG, a subsidiary of BTG plc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Neurological conditions [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLP-1 CellBeads 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298830

Locations
Germany
Neurochirurgische Klinik und Neurologische Klinik des Universitätsklinikums Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Neurochirurgische Klinik der Universität Erlangen-Nürnberg
Erlangen, Bavaria, Germany, 91054
Klinik für Neurochirurgie Klinikum Bogenhausen Akademisches Lehrkrankenhaus der Technischen Universität München
München, Bavaria, Germany, 81925
International Neuroscience Institute
Hannover, Lower Saxony, Germany, 30625
Klinikum Region Hannover Krankenhaus Nordstadt, Klinik für Neurologie
Hannover, Lower Saxony, Germany, 30167
Klinik für Neurochirurgie Medizinische Hochschule Hannover
Hannover, Lower Saxony, Germany, 30625
Sponsors and Collaborators
CellMed AG, a subsidiary of BTG plc.
Investigators
Study Chair: Thomas Brinker, Prof. Dr.med. International Neuroscience Institute Hanover
  More Information

No publications provided

Responsible Party: Dr. med. Peter Geigle / CEO, CellMed AG
ClinicalTrials.gov Identifier: NCT01298830     History of Changes
Other Study ID Numbers: CM GLP-1/01, 2007-004516-31
Study First Received: February 15, 2011
Last Updated: March 25, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014