GLP-1 CellBeads® for the Treatment of Stroke Patients Wit... | NCT01298830

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

NCT01298830

Sponsor

CellMed AG, a subsidiary of BTG plc.

Status

Terminated

Last Update Posted

Mar 26, 2013Estimated

Enrollment

11Actual

Phase

Phase 1Phase 2

Conditions

Intracerebral Hemorrhage (ICH)

Interventions

GLP-1 CellBeads

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-004516-31	EudraCT Number

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Need for improvement of study medication. Safety data collected sufficient. No further gain in knowledge expected.

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Feb 15, 2011

First Submission Date that Met QC Criteria

Feb 16, 2011

First Posted Date

Feb 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2013

Last Update Posted Date

Mar 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GLP-1 CellBeads	Experimental		Drug: GLP-1 CellBeads

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLP-1 CellBeads	Drug	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.

Measure	Description	Time Frame
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage		6 months

Measure	Description	Time Frame
Neurological conditions		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases