Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.

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

The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • 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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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: Experimental group
Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells
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.
Placebo Comparator: Control group
Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Placebo：saline
Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium
Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor function analysis
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological deficits analysis
Time Frame: 6 months

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
Limb motor function analysis
Time Frame: 6 months
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
Barthel Index analysis
Time Frame: 6 months

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

Collaborators and Investigators

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

Sponsor

Sclnow Biotechnology Co., Ltd.

Investigators

  • Study Director: Wulan, 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

May 23, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Estimated)

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-01

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

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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