ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 45 of 184 for:    uMBILICAL CORD MESENCHYMAL STEM CELLS

Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke (Recruiting)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02580019
Recruitment Status : Unknown
Verified July 2015 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : October 20, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Stroke Biological: Human umbilical cord mesenchymal stem cells Phase 2

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cell Therapy by Intravenous Injection of Umbilical Cord Derived Mesenchymal Stem Cells After Stroke
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
No Intervention: conventional stroke treatment
Control group without intervention, whereas they receive conventional stroke treatment that including rehabilitation
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation
Biological: Human umbilical cord mesenchymal stem cells
A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.




Primary Outcome Measures :
  1. Number of treatment related-adverse events during the study period. [ Time Frame: 180 days after transfusion ]

Secondary Outcome Measures :
  1. Comparison of National Institutes of Health stroke scale (NIHSS). [ Time Frame: 180 days after the cell treatment. ]
  2. Comparison of modified Rankin scale (mRS). [ Time Frame: 180 days after the cell treatment. ]
  3. Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days. [ Time Frame: 180 days after the cell treatment. ]
  4. Comparison of infarct size measured by brain MRI. [ Time Frame: 180 days after the cell treatment. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580019


Contacts
Contact: Li De Sheng, P.H.D 13811435365 ext 011-86-126 deshengli301@126.com
Contact: Huang Min, B.S 18310706110 ext 011-86-126 871803864@qq.com

Locations
China, Beijing
Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital)
Beijing, Beijing, China, 100071
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Investigators
Principal Investigator: Duan Lian, P.H.D Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02580019     History of Changes
Other Study ID Numbers: Hospital307
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: July 2015

Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
Cellular therapy
umbilical cord mesenchymal stem cells
Stroke
Neuronal Plasticity
Recovery
Transplantation
Cardiovascular Diseases
Ischemia
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases