Clinical trial NCT01468064: Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke
Official title: Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
Collaborators: name: The Second People's Hospital of Nanhai District of Foshan
name: The First People's Hospital of Haizhu District Guangzhou
name: Cellonis Biotechnology Co. Ltd.
First posted: 2011-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse events after infusion of BMSCs or EPCs.
timeFrame: 1 year
Secondary outcomes:
measure: Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI).
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Neurosurgery, Zhujiang Hospital
name: Zhenzhou Chen, MD., phD.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.