The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ACI) in the Treatment of Acute Cerebral Infarction

Cerebral Infarction Clinical Trial

Official title:

Study the Safety and Efficacy of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03186456
• Other study ID #: SCLnow-IMIMH-02
• Status: Suspended
• Phase: Phase 1
• 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
• Study type: Interventional

Clinical Trial Summary

The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).

Description:

This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Aspirin Tablet). Patients in experimental group will receive hUC-MSC once a month, total 3 times. After the treatment, investigator will have follow-up visit for 6 months, evaluate the security and efficacy of hUC-MSC.

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: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient within 2 weeks onset of symptoms.
• Symptoms and signs of clinically definite acute cerebral infarction patients.
• CT/MRI prove the Oxfordshire Community Stroke Project (OCSP) as Total Anterior circulation infarct (TACI), Partial Anterior circulation infarct (PACI), Posterior Anterior circulation infarct (POCI), or obvious neurological deficit lacunar infarction patient.
• Signed informed consent after understanding all possible benefits and harm.

Exclusion Criteria:

• allergic to basic drug
• with progressive stroke, transient ischemia attach, cerebral infarction with posterior cerebral hemorrhage, and cerebral arteritis.
• tumor, injury, and parasites caused cerebral embolism
• rheumatic heart disease, coronary heart disease, and other atrial fibrillation combined heart disease caused cerebral embolism
• subject is processing thrombolytic therapy
• subject is pregnancy and of childbearing potential or breast feeding
• participate in any other clinical trial in last 3 months
• bleeding tendency patient; severe bleeding tendency in last 3 month
• with gastric duodenal ulcer
• participants with severe liver and kidney, hematopoietic, and metabolic diseases; Or with liver and kidney function examination abnormal
• participants are intolerance with Aspirin Enteric-coated Tablets, or need other antiplatelet drugs
• participants: alcoholism, drug addicted, or other situations may complicated the results
• under other therapy that possibly influence MSC security or efficacy
• investigator supposes not suitable to participate this clinical trail

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Biological:
• Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
Allogeneic umbilical cord mesenchymal stem cells will transfusion into by forearm intravenous transplantation, 0.5 - 1 *10^6/kg. once a month, total 3 times.

Drug:
• Aspirin Tablet
Drug: Aspirin Tablet, 100 mg/d

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	Treatment related-adverse events counting	patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells	26 weeks
Secondary	Modified Rankin Scale	After the first time transplantation, follow-up visit for 26 weeks. Based on Modified Rankin Scale, counting the percentage of different symptom changes to evaluate MSC efficacy: the percentage of participants run from 0-1, no symptom or no significant disability.; the percentage of participants run from 0-2, no symptom or slight disability.; the percentage of participants decline 2 scales compare to baseline.; the percentage of participants decline 1 scale compares to baseline.	26 weeks
Secondary	Barthel activities of daily living (ADL) Index	Based on Activity of Daily Living Scale (ADL) to counting the percentage of patients in following condition: the percentage of patients with score > 75; the decline of Barthel ADL Index range compares to baseline. Evaluate the efficacy of MSCs treatment	26 weeks
Secondary	NIH stroke scale (NIHSS)	According to NIHSS changes after the treatment, evaluate MSCs efficacy by counting the percentage of patients in following condition: the percentage of patients with score 0-1; the percentage of patients with score declined 7 compare to baseline; the percentage of patients with score declined 50% compare to baseline; the declined ranges compare to baseline	26 weeks