Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke

Stroke Clinical Trial

— AMETIS  

Official title:

Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468064
• Other study ID #: ZJH-001
• Secondary ID: 2011A030400007
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2011
• Est. completion date: March 2017

Study information

• Verified date: April 2021
• Source: Southern Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.

Description:

This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients with acute cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs transplantation group, autologous EPCs transplantation group and Placebo control group. Randomization codes were established by the study statistician and were revealed only to the stem cell laboratory technician responsible for separating the cells into aliquots or preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously infused into own body, respectively. The control group will not receive cell therapy. Observe will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality of any cause, side effects, and new-onset comorbidities will be monitored and compared between each groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18 to 80 years, within 7 days of the onset of symptoms

2. Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)

3. The National Institutes of Health Stroke Scale (NIHSS) = 7 at day 7 after the onset

4. Signed informed consent

Exclusion Criteria:

1. Lacunar syndrome

2. Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)

3. Hematological causes of stroke

4. Severe respiratory, hepatic, or renal disorders

5. Presence of severe febrile illness or viral diseases

6. Malignant diseases

7. Presence of autoimmune diseases

8. Positive response of penicillin skin test, or multiple drug allergies

9. Breast-feeding or pregnant women

Related Conditions & MeSH terms

• Infarction
• Infarction, Middle Cerebral Artery
• Stroke

Intervention

Genetic:
• Autologous BMSCs transplantation
The first transplantation: 2.5 million cells per kg autologous BMSCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration. The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.
• Autologous EPCs transplantation
The first transplantation: 2.5 million cells per kg autologous EPCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration. The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.
• IV infusion of placebo
IV infusion of saline plus 5% autologous serum.

Locations

Country	Name	City	State
China	Zhujiang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Southern Medical University, China	Cellonis Biotechnology Co. Ltd., The First People's Hospital of Haizhu District Guangzhou, The Second People's Hospital of Nanhai District of Foshan

Country where clinical trial is conducted

China, 

References & Publications (2)

Bang OY, Lee JS, Lee PH, Lee G. Autologous mesenchymal stem cell transplantation in stroke patients. Ann Neurol. 2005 Jun;57(6):874-82. — View Citation

Lee JS, Hong JM, Moon GJ, Lee PH, Ahn YH, Bang OY; STARTING collaborators. A long-term follow-up study of intravenous autologous mesenchymal stem cell transplantation in patients with ischemic stroke. Stem Cells. 2010 Jun;28(6):1099-106. doi: 10.1002/stem.430. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events after infusion of BMSCs or EPCs.		1 year
Secondary	Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI).		1 year