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

Primary Purpose

Cerebral Infarction

Status

Suspended

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

Aspirin Tablet

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring acute cerebral infarction, umbilical cord mesenchymal stem cells

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Inner Mongolia International Mongolian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg

Aspirin Tablet, 100mg/d; Placebo

Outcomes

Primary Outcome Measures

Treatment related-adverse events counting

patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells

Secondary Outcome Measures

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.

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

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

Full Information

NCT ID

NCT03186456

First Posted

June 6, 2017

Last Updated

April 11, 2023

Sponsor

Sclnow Biotechnology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03186456

Brief Title

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

Official Title

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

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Infarction

Keywords

acute cerebral infarction, umbilical cord mesenchymal stem cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg

Arm Title

Group 2

Arm Type

Placebo Comparator

Arm Description

Aspirin Tablet, 100mg/d; Placebo

Intervention Type

Biological

Intervention Name(s)

Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Aspirin Tablet

Intervention Description

Drug: Aspirin Tablet, 100 mg/d

Primary Outcome Measure Information:

Title

Treatment related-adverse events counting

Description

patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Modified Rankin Scale

Description

Time Frame

26 weeks

Title

Barthel activities of daily living (ADL) Index

Description

Time Frame

26 weeks

Title

NIH stroke scale (NIHSS)

Description

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Temuqile

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

Learn more about this trial

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

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