Implantation of Olfactory Ensheathing Cells (OECs)

China Medical University

Status and phase

Unknown

Phase 1

Conditions

Infarction, Middle Cerebral Artery

Stroke With Hemiparesis,

Ischemic Stroke,

Thromboembolic Stroke.

Treatments

Procedure: Olfactory ensheathing cells

Study type

Interventional

Funder types

Other

Identifiers

NCT01327768

CN1U00-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 estimated patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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.