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

Primary Purpose

Intracerebral Hemorrhage (ICH)

Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
GLP-1 CellBeads
Sponsored by
CellMed AG, a subsidiary of BTG plc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Intracerebral Hemorrhage (ICH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurochirurgische Klinik und Neurologische Klinik des Universitätsklinikums Heidelberg
  • Neurochirurgische Klinik der Universität Erlangen-Nürnberg
  • Klinik für Neurochirurgie Klinikum Bogenhausen Akademisches Lehrkrankenhaus der Technischen Universität München
  • Klinikum Region Hannover Krankenhaus Nordstadt, Klinik für Neurologie
  • International Neuroscience Institute
  • Klinik für Neurochirurgie Medizinische Hochschule Hannover

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GLP-1 CellBeads

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Neurological conditions

Full Information

First Posted
February 15, 2011
Last Updated
March 25, 2013
Sponsor
CellMed AG, a subsidiary of BTG plc.
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1. Study Identification

Unique Protocol Identification Number
NCT01298830
Brief Title
GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage
Official Title
GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Need for improvement of study medication. Safety data collected sufficient. No further gain in knowledge expected.
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CellMed AG, a subsidiary of BTG plc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage (ICH)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLP-1 CellBeads
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GLP-1 CellBeads
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Neurological conditions
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Brinker, Prof. Dr.med.
Organizational Affiliation
International Neuroscience Institute Hanover
Official's Role
Study Chair
Facility Information:
Facility Name
Neurochirurgische Klinik und Neurologische Klinik des Universitätsklinikums Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Neurochirurgische Klinik der Universität Erlangen-Nürnberg
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinik für Neurochirurgie Klinikum Bogenhausen Akademisches Lehrkrankenhaus der Technischen Universität München
City
München
State/Province
Bavaria
ZIP/Postal Code
81925
Country
Germany
Facility Name
Klinikum Region Hannover Krankenhaus Nordstadt, Klinik für Neurologie
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30167
Country
Germany
Facility Name
International Neuroscience Institute
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinik für Neurochirurgie Medizinische Hochschule Hannover
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

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

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