NCT03384433

Brief Summary

Administration of cell-free exosomes derived from mesenchymal stem cell (MSCs) can be sufficient to exert therapeutic effects of intact MSCs after brain injury. In this study we aim to assay the administration of MSC derived exosome on improvement of disability of patients with acute ischemic stroke

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 17, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

November 29, 2017

Last Update Submit

January 21, 2021

Conditions

Cerebrovascular Disorders

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation

    12 months

Secondary Outcomes (1)

  • measurement of Modified Ranking Scale

    12 months

Study Arms (1)

exosome or vesicle

EXPERIMENTAL

CVA patients who have disability, will receive total protein of allogenic MSC-generated exosome transfected by miR-124, one month after attack, via Stereotaxis/Intraparanchymal

Biological: exosome

Interventions

exosomeBIOLOGICAL

allogenic mesenchymal stem cells derived exosome enriched by miR-124

exosome or vesicle

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female acute ischemic patients aged 40-80 years with symptoms of acute cerebral infarction of less than 24h from stroke onset.
  • Patients with infarct size 3\*3
  • Patients with a measurable focal neurological that must persist to the time of treatment without clinically meaningful improvement.
  • Patients must have computerized tomography (CT) and / or magnetic resonance imaging (MRI) compatible with the clinical diagnosis of acute ischemic stroke in the territory of the middle cerebral artery before being included in the study.
  • Patients must have a score on the NIH Stroke Scale 8-24, and mRS ≤ 1
  • Obtaining informed consent signed

You may not qualify if:

  • Comatose patients.
  • brain tumour, cerebral oedema with compression of ventricles, cerebellar infarction or brainstem, or intraventricular, intracerebral or subarachnoid haemorrhage.
  • alcohol use Active infectious disease, including HIV, hepatitis B, Hepatitis .
  • patients with dementia.
  • Specify clinical conditions
  • Patients who are participating in another clinical trial.
  • Inability or unwillingness of individual for giving written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Beheshti University of Medical Sciences

Tehran, Iran

RECRUITING

Related Publications (1)

  • Aldali F, Deng C, Nie M, Chen H. Advances in therapies using mesenchymal stem cells and their exosomes for treatment of peripheral nerve injury: state of the art and future perspectives. Neural Regen Res. 2025 Nov 1;20(11):3151-3171. doi: 10.4103/NRR.NRR-D-24-00235. Epub 2024 Oct 22.

    PMID: 39435603DERIVED

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Saeed Oraee-Yazdani, Dr

    Shahid Beheshti University of Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Masoud Soleimani, Prof

CONTACT

09122875993soleim_m@modares.ac.ir

Leila Dehghani, Assis

CONTACT

09131363593l_dehghani2002@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Masoud Soleimani

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 27, 2017

Study Start

April 17, 2019

Primary Completion

June 17, 2021

Study Completion

December 17, 2021

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

IR(1)