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

This study is not yet open for participant recruitment.
Verified June 2017 by Sclnow Biotechnology Co., Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176498
First Posted: June 5, 2017
Last Update Posted: June 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.
  Purpose
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 Intervention Phase
Cerebral Infarction Biological: Allogeneic umbilical cord mesenchymal stem cell Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium Phase 1 Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Sclnow Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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

  • 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.



Estimated Enrollment: 40
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
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
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


Contacts
Contact: Lei Guo 861064368977 georgeguo@sclnow.com

Locations
China, Inner Mongolia
Inner Mongolia International Mongolian Hospital Not yet recruiting
Hohhot, Inner Mongolia, China, 010065
Contact: Wulantuya    864715182155      
Sponsors and Collaborators
Sclnow Biotechnology Co., Ltd.
Investigators
Study Director: Wulan Inner Mongolia International Mongolian Hospital
Study Chair: Lei Guo, Dr Jilin University
  More Information

Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03176498     History of Changes
Other Study ID Numbers: SCLnow-IMIMH-01
First Submitted: May 23, 2017
First Posted: June 5, 2017
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Infarction
Cerebral 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
Calcium, Dietary
Aspirin
Atorvastatin Calcium
Bone Density Conservation 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