NCT01518231

Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke

Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zhejiang Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.

Detailed description

Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.

Conditions

• Stroke

Interventions

Type	Name	Description
PROCEDURE	autologous hematopoiesis stem cell transplantation	Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.
DRUG	Aspirin	aspirin 100mg,qd,po(patients with no fibrillation atrial)
DRUG	Warfarin	warfarin 2\~6mg,qd,po(patients with fibrillation atrial);
DRUG	Atorvastatin	atorvastatin 20mg,qd,po
DRUG	Edaravone	edaravone 30mg,bid,ivgtt.
DRUG	Aspirin	aspirin 100mg,qd,po(patients with no fibrillation atrial)
DRUG	Warfarin	warfarin 2\~6mg,qd,po(patients with fibrillation atrial)
DRUG	Atorvastatin	atorvastatin 20mg,qd,po
DRUG	Edaravone	edaravone 30mg,bid,ivgtt

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2012-01-25
• Last updated: 2012-01-25

Locations

1 site across 1 country: China