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

March 25, 2013 updated by: CellMed AG, a subsidiary of BTG plc.
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Neurochirurgische Klinik und Neurologische Klinik des Universitätsklinikums Heidelberg
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Neurochirurgische Klinik der Universität Erlangen-Nürnberg
      • München, Bavaria, Germany, 81925
        • Klinik für Neurochirurgie Klinikum Bogenhausen Akademisches Lehrkrankenhaus der Technischen Universität München
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30167
        • Klinikum Region Hannover Krankenhaus Nordstadt, Klinik für Neurologie
      • Hannover, Lower Saxony, Germany, 30625
        • International Neuroscience Institute
      • Hannover, Lower Saxony, Germany, 30625
        • Klinik für Neurochirurgie Medizinische Hochschule Hannover

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurological conditions
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CellMed AG, a subsidiary of BTG plc.

Investigators

  • Study Chair: Thomas Brinker, Prof. Dr.med., International Neuroscience Institute Hanover

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM GLP-1/01
  • 2007-004516-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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