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

April 18, 2024 updated by: Sclnow Biotechnology Co., Ltd.

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

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).

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010065
        • Inner Mongolia International Mongolian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg
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
Placebo Comparator: Group 2
Aspirin Tablet, 100mg/d; Placebo
Drug: Aspirin Tablet
Drug: Aspirin Tablet, 100 mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment related-adverse events counting
Time Frame: 26 weeks
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale
Time Frame: 26 weeks

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
Barthel activities of daily living (ADL) Index
Time Frame: 26 weeks

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
NIH stroke scale (NIHSS)
Time Frame: 26 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sclnow Biotechnology Co., Ltd.

Investigators

  • Study Director: Temuqile, Inner Mongolia International Mongolian Hospital
  • Study Chair: Lei Guo, Dr., China-Japan Union Hospital, Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCLnow-IMIMH-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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