Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.
Primary Purpose
Cerebral Infarction
Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Allogeneic umbilical cord mesenchymal stem cell
Aspirin Enteric-coated Tablets & Atorvastatin Calcium
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Infarction focused on measuring cerebral Infarction, umbilical cord mesenchymal stem cells
Eligibility 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
Sites / Locations
- Inner Mongolia International Mongolian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Allogeneic umbilical cord mesenchymal stem cells
Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Placebo:saline
Outcomes
Primary Outcome Measures
Motor function analysis
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
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
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
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.
Full Information
NCT ID
NCT03176498
First Posted
May 23, 2017
Last Updated
April 11, 2023
Sponsor
Sclnow Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03176498
Brief Title
Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.
Official Title
The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
Others
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sclnow Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
cerebral Infarction, umbilical cord mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Allogeneic umbilical cord mesenchymal stem cells
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Placebo:saline
Intervention Type
Biological
Intervention Name(s)
Allogeneic umbilical cord mesenchymal stem cell
Intervention Description
Experimental group receive Allogeneic umbilical cord mesenchymal stem cell,i.v (SCLnow 19#)
Intervention Type
Drug
Intervention Name(s)
Aspirin Enteric-coated Tablets & Atorvastatin Calcium
Intervention Description
Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.
Primary Outcome Measure Information:
Title
Motor function analysis
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Neurological deficits analysis
Description
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.
Time Frame
6 months
Title
Limb motor function analysis
Description
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
Time Frame
6 months
Title
Barthel Index analysis
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wulan
Organizational Affiliation
Inner Mongolia International Mongolian Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lei Guo, Dr
Organizational Affiliation
China-Japan Union Hospital, Jilin University
Official's Role
Study Chair
Facility Information:
Facility Name
Inner Mongolia International Mongolian Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010065
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.
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