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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03176498
Other study ID # SCLnow-IMIMH-01
Secondary ID
Status Suspended
Phase Phase 1/Phase 2
First received
Last updated
Start date December 31, 2024
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Sclnow Biotechnology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Inner Mongolia International Mongolian Hospital Hohhot Inner Mongolia

Sponsors (1)

Lead Sponsor Collaborator
Sclnow Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Secondary 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.
6 months
Secondary 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 6 months
Secondary 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.
6 months
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