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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.

Tracking Information
First Submitted Date  ICMJE May 23, 2017
First Posted Date  ICMJE June 5, 2017
Last Update Posted Date October 28, 2020
Estimated Study Start Date  ICMJE October 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Umbilical Cord Mesenchymal Stem Cell Therapy for Cerebral Infarction Patients in Convalescent Period.
Official Title  ICMJE The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Infarction
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Experimental group
    Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Allogeneic umbilical cord mesenchymal stem cells
    Interventions:
    • Biological: Allogeneic umbilical cord mesenchymal stem cell
    • Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium
  • Placebo Comparator: Control group
    Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Placebo:saline
    Intervention: Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 31, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03176498
Other Study ID Numbers  ICMJE SCLnow-IMIMH-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sclnow Biotechnology Co., Ltd.
Study Sponsor  ICMJE Sclnow Biotechnology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wulan Inner Mongolia International Mongolian Hospital
Study Chair: Lei Guo, Dr China-Japan Union Hospital, Jilin University
PRS Account Sclnow Biotechnology Co., Ltd.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP