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

NCT01468064 | Completed Phase 1

• 2 other identifiers: ZJH-0012011A030400007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Infarction, Middle Cerebral Artery

Keywords

Central Nervous System Diseases; Stroke; Infarction, Middle Cerebral Artery; Cerebral Infarction; Cerebrovascular Accident; Stem Cell Transplantation; Mesenchymal Stem Cell Transplantation; Bone marrow stromal cells; Mesenchymal Stem Cells; Endothelial progenitor cells; Adult Stem Cells; Cell Therapy

Outcome Measures

Primary Outcomes (1)

• Number of adverse events after infusion of BMSCs or EPCs.

  1 year

Secondary Outcomes (1)

• Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI).

  1 year

Study Arms (3)

BMSCs group

EXPERIMENTAL

Genetic: Autologous BMSCs transplantation

EPCs group

EXPERIMENTAL

Genetic: Autologous EPCs transplantation

Control group

PLACEBO COMPARATOR

Genetic: IV infusion of placebo

Interventions

Autologous BMSCs transplantation GENETIC

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.

Also known as: Autologous Bone marrow stromal cells transplantation, Autologous Mesenchymal stem cells transplantation

BMSCs group

Autologous EPCs transplantation GENETIC

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.

Also known as: Autologous endothelial progenitor cells transplantation

EPCs group

IV infusion of placebo GENETIC

IV infusion of saline plus 5% autologous serum.

Also known as: Placebo control group

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 80 years, within 7 days of the onset of symptoms
• Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)
• The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset
• Signed informed consent

You may not qualify if:

• Lacunar syndrome
• Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)
• Hematological causes of stroke
• Severe respiratory, hepatic, or renal disorders
• Presence of severe febrile illness or viral diseases
• Malignant diseases
• Presence of autoimmune diseases
• Positive response of penicillin skin test, or multiple drug allergies
• Breast-feeding or pregnant women

Sponsors & Collaborators

• Southern Medical University, China: lead
• The Second People's Hospital of Nanhai District of Foshan: collaborator
• The First People's Hospital of Haizhu District Guangzhou: collaborator
• Cellonis Biotechnology Co. Ltd.: collaborator

Study Sites (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 510282, China

Location

Related Publications (3)

• 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.

  PMID: 20506226 BACKGROUND

• Bang OY, Lee JS, Lee PH, Lee G. Autologous mesenchymal stem cell transplantation in stroke patients. Ann Neurol. 2005 Jun;57(6):874-82. doi: 10.1002/ana.20501.

  PMID: 15929052 BACKGROUND

• Fang J, Guo Y, Tan S, Li Z, Xie H, Chen P, Wang K, He Z, He P, Ke Y, Jiang X, Chen Z. Autologous Endothelial Progenitor Cells Transplantation for Acute Ischemic Stroke: A 4-Year Follow-Up Study. Stem Cells Transl Med. 2019 Jan;8(1):14-21. doi: 10.1002/sctm.18-0012. Epub 2018 Aug 29.

  PMID: 30156755 DERIVED

MeSH Terms

Conditions

Stroke; Infarction, Middle Cerebral Artery; Central Nervous System Diseases; Cerebral Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Zhenzhou Chen, MD., phD.

  Department of Neurosurgery, Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurosurgery, Zhujiang Hospital

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 9, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2017
• Last Updated: April 2, 2021

Record last verified: 2021-04

Locations

CN (1)