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Human Umbilical Cord Mesenchymal Stem Cell Therapy for Cerebral Infarction Patients in Convalescent Period.

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ClinicalTrials.gov Identifier: NCT03176498
Recruitment Status : Suspended (Others)
First Posted : June 5, 2017
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.

Study Description
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Brief Summary:
This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Biological: Allogeneic umbilical cord mesenchymal stem cell Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium Phase 1 Phase 2

Detailed Description:
40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. All participants will sign informed consent form, monitor vital signs, laboratory examination (CT/MRI, blood routine examination, urine routine examination, liver function, renal function, etc.), NIHSS, Fugl-Meyer analysis (FMA) 0-3 days before treatment. All of them will receive basic treatment with Aspirin Enteric-coated Tablets and Atorvastatin Calcium. And experimental group will treat with hUC-MSC, control group with placebo (normal saline) on the 7th and 14th day. After the treatment, investigator will follow-up, monitor vital signs, laboratory examination, NIHSS, FMA analysis on 2 weeks, 1 month, and 6 months after the treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group
Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells
 Biological: Allogeneic umbilical cord mesenchymal stem cell
Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)

Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium
Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.
Placebo Comparator: Control group
Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Placebo：saline
 Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium
Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.


Outcome Measures
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Primary Outcome Measures :
  1. Motor function analysis [ Time Frame: 6 months ]
    Based on Activity of Daily Living Scale (ADL) to analysis efficacy of cell treatment.The score of patient with upper limb >60, and total score >90 is considered good recovery.


Secondary Outcome Measures :
  1. Neurological deficits analysis [ Time Frame: 6 months ]

    According to Chinese scale of clinical neurologic deficit to analysis, the result as follow:

    • Excellent: after treatment, patient with consciousness, and clinical symptoms improved;
    • Effective: vital signs and main symptoms in remission;
    • Inefficient: no obvious improvement or condition worsened.

  2. Limb motor function analysis [ Time Frame: 6 months ]
    Using fugl-meyer assessment evaluate motor function. Mild movement disorder: 96 - 99; Moderate movement disorder: 85 - 95; Obvious movement disorder: 50 - 84; Serious movement disorder: < 50

  3. Barthel Index analysis [ Time Frame: 6 months ]

    Obvious effective: Barthel Index score between 96 - 99, patient with self care ability.

    Effective:Barthel Index score between 70 - 89, patient with condition improved. Invalid: The effect do not meet above standards.



Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • proved cerebral infarction by CT or MRI.
  • no cerebrovascular disease before
  • signed informed consent form

Exclusion Criteria:

  • serious body and intracranial lesions (tumor, infection, etc.)
  • patients repeated cerebral infarction attacks
  • multi-foci of cerebral infarction
  • history of drug dependence and mental disease
  • disturbance of consciousness and non-compliance patients
  • subjects who are HIV positive
  • pregnant or lactation
  • donor: HIV infected, Active hepatitis B/C infected, Syphilis antibody positive
  • subjects/ donor: alcoholism, drug addicts or mental disease
Contacts and Locations
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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): NCT03176498


Locations
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China, Inner Mongolia
Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, China, 010065
Sponsors and Collaborators
Sclnow Biotechnology Co., Ltd.
Investigators
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Study Director: Wulan Inner Mongolia International Mongolian Hospital
Study Chair: Lei Guo, Dr China-Japan Union Hospital, Jilin University
More Information
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Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03176498    
Other Study ID Numbers: SCLnow-IMIMH-01
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sclnow Biotechnology Co., Ltd.:
cerebral Infarction
umbilical cord mesenchymal stem cells
Additional relevant MeSH terms:
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Cerebral Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Aspirin
 Atorvastatin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors