Clinical trial NCT02580019: Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke
Official title: Cell Therapy by Intravenous Injection of Umbilical Cord Derived Mesenchymal Stem Cells After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke
Keywords: Cellular therapy
Stroke
Neuronal Plasticity
Recovery
umbilical cord mesenchymal stem cells
Transplantation
Cardiovascular Diseases
Ischemia
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims at estimating the safety and efficacy of the intravenous injection of human umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in recent 3 months.

Detailed description: Given the attention paid in recent times, in China and elsewhere, to stroke, which is the leading cause of acquired adult disability and has negative effects on patients' quality of life.Therefore,It's little wonder there's much focus there days on treatment of stroke. For the patients who have suffered from ischemic stroke in 3 months, indeed, they have the opportunity to get symptomatic improvement through receiving conventional stroke treatments that including rehabilitation. At the same time, these treatments are ineffective in some cases. Alternatively, the phenomenon of increasing brain plasticity after stroke provoke an essential therapy. Human umbilical cord mesenchymal stem cells treatment enhances a functional improvement after cerebral ischemia, likewise, treament in rodent models are proved effective. Human umbilical cord mesenchymal stem cells therapy performs a role as take the place destroyed cerebral tissue with a stem cells graft. The totality of evidence from trials running umbilical cord mesenchymal stem cells transplanted into patients suffering from ischemic stroke support the safety of this approach. In terms of efficacy, positive results are reported in the majority of the trials.

Our research project involves a development of cell therapy in a phase IIa clinical trial of safety and efficacy in patients (randomised, controlled, open, with 2 parallel groups).

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of intracerebral ischemic stroke in three months by Magnetic Resonance Imaging(MRI)
* Patients have received proper treatment within two weeks from the onset of stroke symptoms.
* Age between 18 to 70 years old for men or women
* Patients with persistent neurological deficit .
* Obtaining informed consent signed (after being informed of the purpose, procedure, and venture of this study, the patient or guardian or legal representative must signing the informed consent document for engagement of participation.
* Patients basic situation are allowable to be involved in the program.

Exclusion Criteria:

* Patients with serious extensive stroke, who are unwilling to the risk.
* Patients with serious persistent neurological deficit (NIHSS \> 24).
* Medical history of neurological pathology with a deficit as consequence (Rankin \< 3 before stroke).
* Patients with serious psychological disease.
* Patients with myocardial infarction in recent 3 months.
* Patients with recurring thromboembolic disease in recentin recent 3 months.
* Patients with organ transplantation.
* Patients with infection history including Human Immunodeficiency Virus(HIV),Human T-cell Leukemia Virus(HTLV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV),ect.
* Patients receive current immunosuppressive/immunomodulating treatment.
* Patients basic situation are unallowable to be involved in the program.
* Patients who refuse to participate.
* Patients who are inability or unwillingness of individual or legal guardian/representative to give written informed consent.
* Patients who are pregnant or feeding women.
* Patients who are Participating in another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.

Primary outcomes:
measure: Number of treatment related-adverse events during the study period.
timeFrame: 180 days after transfusion
Secondary outcomes:
measure: Comparison of National Institutes of Health stroke scale (NIHSS).
timeFrame: 180 days after the cell treatment.
measure: Comparison of modified Rankin scale (mRS).
timeFrame: 180 days after the cell treatment.
measure: Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days.
timeFrame: 180 days after the cell treatment.
measure: Comparison of infarct size measured by brain MRI.
timeFrame: 180 days after the cell treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital)
state: Beijing
Study officials:
affiliation: Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China
name: Duan Lian, P.H.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng Q, Zhang Z, Zhang S, Yang H, Zhang X, Pan J, Weng L, Sha D, Zhu M, Hu X, Xu Y. Human umbilical cord mesenchymal stem cells protect against ischemic brain injury in mouse by regulating peripheral immunoinflammation. Brain Res. 2015 Jan 12;1594:293-304. doi: 10.1016/j.brainres.2014.10.065. Epub 2014 Nov 6.
citation: Tsuji M, Taguchi A, Ohshima M, Kasahara Y, Sato Y, Tsuda H, Otani K, Yamahara K, Ihara M, Harada-Shiba M, Ikeda T, Matsuyama T. Effects of intravenous administration of umbilical cord blood CD34(+) cells in a mouse model of neonatal stroke. Neuroscience. 2014 Mar 28;263:148-58. doi: 10.1016/j.neuroscience.2014.01.018. Epub 2014 Jan 18.
citation: Verina T, Fatemi A, Johnston MV, Comi AM. Pluripotent possibilities: human umbilical cord blood cell treatment after neonatal brain injury. Pediatr Neurol. 2013 May;48(5):346-54. doi: 10.1016/j.pediatrneurol.2012.10.010.
citation: Yalvac ME, Rizvanov AA, Kilic E, Sahin F, Mukhamedyarov MA, Islamov RR, Palotas A. Potential role of dental stem cells in the cellular therapy of cerebral ischemia. Curr Pharm Des. 2009;15(33):3908-16. doi: 10.2174/138161209789649439.