NCT01298830

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2008

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2013

Enrollment Period

2.7 years

First QC Date

February 15, 2011

Last Update Submit

March 25, 2013

Conditions

Intracerebral Hemorrhage (ICH)

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

  • Neurological conditions

    6 months

Study Arms (1)

GLP-1 CellBeads

EXPERIMENTAL
Drug: GLP-1 CellBeads

Interventions

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.

GLP-1 CellBeads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participation in any other clinical trial within the past 3 months or ongoing
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Neurochirurgische Klinik und Neurologische Klinik des Universitätsklinikums Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Neurochirurgische Klinik der Universität Erlangen-Nürnberg

Erlangen, Bavaria, 91054, Germany

Location

Klinik für Neurochirurgie Klinikum Bogenhausen Akademisches Lehrkrankenhaus der Technischen Universität München

München, Bavaria, 81925, Germany

Location

Klinikum Region Hannover Krankenhaus Nordstadt, Klinik für Neurologie

Hanover, Lower Saxony, 30167, Germany

Location

International Neuroscience Institute

Hanover, Lower Saxony, 30625, Germany

Location

Klinik für Neurochirurgie Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Brinker, Prof. Dr.med.

    International Neuroscience Institute Hanover

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 18, 2011

Study Start

October 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 26, 2013

Record last verified: 2013-03

Locations

DE(6)