Intracerebral Hemorrhage (ICH)Phase 1/2NCT01298830
GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage
A Phase 1/2 study testing GLP-1 CellBeads in people with Intracerebral Hemorrhage (ICH), run by CellMed AG, a subsidiary of BTG plc. at 6 sites in Germany.
Trial summary
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage (ICH)
- What is being tested?
- GLP-1 CellBeads
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 6 sitesGermany
- Study dates
- Oct 2008to Jun 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Neurochirurgische Klinik der Universität Erlangen-Nürnberg
Erlangen, Bavaria, 91054
Klinikum Region Hannover Krankenhaus Nordstadt, Klinik für Neurologie
Hanover, Lower Saxony, 30167
International Neuroscience Institute
Hanover, Lower Saxony, 30625
Klinik für Neurochirurgie Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Neurochirurgische Klinik und Neurologische Klinik des Universitätsklinikums Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Klinik für Neurochirurgie Klinikum Bogenhausen Akademisches Lehrkrankenhaus der Technischen Universität München
München, Bavaria, 81925
About this study
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage.
- Conditions
- Intracerebral Hemorrhage (ICH)
- Being tested
- GLP-1 CellBeads
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 CellBeadsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 CellBeads | Experimental | Not described Receives: Drug: GLP-1 CellBeads |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage
Measured: 6 months
Secondary outcomes (1)
Neurological conditions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Need for improvement of study medication. Safety data collected sufficient. No further gain in knowledge expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral Hemorrhage (ICH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- CellMed AG, a subsidiary of BTG plc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Brinker, Prof. Dr.med., Study chair, International Neuroscience Institute Hanover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298830
- Sponsor's protocol ID
- CM GLP-1/01
- Other IDs
- 2007-004516-31
- Status last verified
- Mar 2013
- First submitted
- 15 Feb 2011
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT01298830
- Acronym / sponsor ID
- CM GLP-1/01
- Conditions
- Intracerebral Hemorrhage (ICH)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Need for improvement of study medication. Safety data collected sufficient. No further gain in knowledge expected.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- CellMed AG, a subsidiary of BTG plc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-1 CellBeads | Experimental | Drug: GLP-1 CellBeads |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 CellBeadsGLP-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. | Drug | GLP-1 CellBeads |
Primary outcome
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
1 secondary outcome
Neurological conditions
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Need for improvement of study medication. Safety data collected sufficient. No further gain in knowledge expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Brinker, Prof. Dr.med. study chair
International Neuroscience Institute Hanover
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GLP-1 CellBeads in people with Intracerebral Hemorrhage (ICH), run by CellMed AG, a subsidiary of BTG plc. at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Need for improvement of study medication. Safety data collected sufficient. No further gain in knowledge expected.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013.