Human Umbilical Cord Mesenchymal Stem Cell Therapy for Cerebral Infarction Patients in Convalescent Period.


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Verified May 2017 by Sclnow Biotechnology Co., Ltd.

Sponsor:

Information provided by (Responsible Party):

Sclnow Biotechnology Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03176498

First received: May 23, 2017

Last updated: May 31, 2017

Last verified: May 2017

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.

Cerebral Infarction Biological: Allogeneic umbilical cord mesenchymal stem cell
Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 40
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
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.

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.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03176498

Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, China, 010065
Contact: Wulantuya    864715182155      

Sclnow Biotechnology Co., Ltd.

Study Chair: Wulan Inner Mongolia International Mongolian Hospital

Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03176498     History of Changes
Other Study ID Numbers: SCLnow-IMIMH-01
Study First Received: May 23, 2017
Last Updated: May 31, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sclnow Biotechnology Co., Ltd.:

cerebral Infarction
umbilical cord mesenchymal stem cells

Additional relevant MeSH terms:

Infarction
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Calcium, Dietary
Atorvastatin Calcium
Aspirin
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on June 05, 2017