Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke (AHSCTIS)

Zhejiang Hospital

Status and phase: Unknown; Phase 1

Conditions: Stroke

Treatments: Drug: Atorvastatin; Drug: Aspirin; Drug: Warfarin; Drug: Edaravone; Procedure: autologous hematopoiesis stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01518231

Zhejiang Hospital

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 40~70
• no consciousness disorders
• internal carotid artery territory infarction
• stroke happened < 1 year
• with stable hemiplegia, but remain dependent in daily life
• SSS(Scandinavian Stroke Scale) < 40

Exclusion criteria

• pregnant women
• can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

cell transplantation

Experimental group

Description:

The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.

Treatment:

Drug: Atorvastatin

Drug: Atorvastatin

Drug: Aspirin

Drug: Edaravone

Drug: Warfarin

Drug: Aspirin

Procedure: autologous hematopoiesis stem cell transplantation

Drug: Edaravone

Drug: Warfarin

Convention therapy

No Intervention group

Description:

The control group just receive drug therapy.

Treatment:

Drug: Atorvastatin

Drug: Atorvastatin

Drug: Aspirin

Drug: Edaravone

Drug: Warfarin

Drug: Aspirin

Drug: Edaravone

Drug: Warfarin