Implantation of Olfactory Ensheathing Cells (OECs) (OECs)

September 29, 2011 updated by: China Medical University Hospital

Evaluation of Safety, Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells

Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The Olfactory Ensheathing Cells (OECs) will be cultured and expanded under the rule of GTP. Then, quality control of OECs should be done by immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

(1)Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The OECs will be cultured and expanded under the rule of GTP. Then, quality control of OECs should be done by immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators will transplanted the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain. (2) Combination with traditional drug therapy (such as used the anti-thrombosis reagent or anti-platelet aggregation reagent). (3) NIH-stroke scale (NIHSS), European stroke scale (ESS), European stroke motor subscale (EMS), Barthel Index(BI) and MMSE will be performed for each patient to evaluate the therapeutic effect as the primary end points. (4) In addition, MRI(DTI) & TMS(MEP) will be also checked for each recruitment patient as the secondary end points.

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • 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 Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital, Center of Neuropsychiatry
        • Contact:
        • Principal Investigator:
          • Woei-Cherng Shyu, M.D., Ph.D

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

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 35-70 year old Chronic Stroke Adult Patients,
  • With Stroke History of More Than 6 Months, Less Than 60 Months,
  • With Stable Hemiplegia Condition,
  • NIHSS Score Is Between 5~15.

Exclusion Criteria:

  • Patients Aged Less Than 35 or More Than 70,
  • Hemorrhage Stroke or MRI Show The Occlusion Is Not In The Middle Cerebral Artery Territory,
  • NIHSS Is Not In The Range of 5~15,
  • Pregnant Women,
  • Impaired Liver Function, Abnormal Blood Coagulation, AIDS Carrier, Tumors, Other Special Conditions, etc.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OECs, Medicine, Rehabilitation
Stroke patients are received intracerebral implantation of Olfactory ensheathing cells(OECs), Antiplatelet Medication, and Rehabilitation.
Procedure: Olfactory ensheathing cells
Recruited patients should be received the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The OECs will be cultured and expanded under the rule of GTP. Finally, we will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain for old stroke ischemic patients.
Other Names:
  • Stroke,
  • Stem Cells,
  • Olfactory Ensheathing Cells,
  • Early Phase Clinical Trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIH-Stroke Scale
Time Frame: within 1 year after surgery
National Institute of Health-Stroke Scale will be performed to evaluate including muscle power of hemiparetic limbs, sensory function and flurency of speech of each patient to document the therapeutic effect.
within 1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI(DTI)
Time Frame: within 1 year after surgery
Magnetic Resonance Image (Diffusion Tensor Image) will be performed to evaluate the increase of the number of fiber tracts (pyramidal tract) in the stroke brain of each patient to document the therapeutic effect.
within 1 year after surgery
TMS(MEP)
Time Frame: within 1 year after surgery
Trans-cranial Magnetic Stimulation (Motor Evoked Potential) will be performed to evaluate the electrophysiological response of stroke brain of each patient to document the therapeutic effect.
within 1 year after surgery

Collaborators and Investigators

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

Sponsor

China Medical University Hospital

Investigators

  • Study Chair: Woei-Cherng Shyu, M.D., Ph.D, shyu9423@gmail.com

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

January 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2013

Study Completion (ANTICIPATED)

May 1, 2013

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (ESTIMATE)

April 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2011

Last Update Submitted That Met QC Criteria

September 29, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN1U00-1

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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