Protocol summary
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Study aim
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safety of hEnSCs injection in SPMS female patients.
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Design
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an open label phase 1 clinical trial to assess safety and Feasibility of hEnSCs on 10 female with SPMS
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Settings and conduct
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Patient recruitment are performed in Sina Hospital.. Endometrial tissue biopsy , hEnSCs isolation, characterization, and culture for IV injection are done and The injection of cells prepared is also done by a neurosurgeon at Sina hospital . Next we evaluate the effect of hEnSCs on patients by assessment of MRI scans on baseline, 6 and 9 months after transplantation.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria:
Women with SPMS
Age between 18–45 years , EDSS less than 5.5, Disease duration of more than 2 and less than 15 years, Women who are taking Rituximab drugs
The Exclusion criteria:
Pregnant patients , patients with other systemic or endometriosis and other uterine problems ,Patients with positive results from screening tests (HBV,HCV,HIV,HTLV)
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Intervention groups
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The effect of hEnSCs on 10 female with SPMS
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Main outcome variables
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Efficacy of hEnSCs on neurophysiological functions , Improvement in clinical evaluations and immunological procedures
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190711044175N1
Registration date:
2019-12-25, 1398/10/04
Registration timing:
registered_while_recruiting
Last update:
2021-02-23, 1399/12/05
Update count:
1
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Registration date
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2019-12-25, 1398/10/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-12-21, 1398/09/30
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Expected recruitment end date
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2021-12-21, 1400/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Cell therapy using human endometrial stem cell(hEnSCs) in patients with Secondary progressive-MS(SPMS): Phase I clinical trial
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Public title
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The effect of hEnSCs transplantation in the treatment of SPMS
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
(1)Women with SPMS who did not respond to their disease-modifying therapies .
(2) Age between 18–45 years
(3) EDSS less than 5.5
(4) Disease duration of 2 - 15 years..
(5) Women with at least one delivery
(6) Women who are taking Rituximab drugs
Exclusion criteria:
Women under the age of 18 and over 45 years
Pregnant patients
Patients with positive results from screening tests for hepatitis B and C, human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) were also excluded from the study.
Patients who had used cytotoxic agents or hormonal therapy within 3 months prior to the study .
Patients with endometriosis and other uterine problems
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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1
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Groups that have been masked
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No information
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Sample size
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Target sample size:
10
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-11-29, 1398/09/08
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.662
Health conditions studied
1
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Description of health condition studied
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Multiple Sclerosis
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ICD-10 code
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G35-G37
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ICD-10 code description
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Demyelinating diseases of the central nervous system, multiple sclerosis
Primary outcomes
1
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Description
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Safety and side effects of hEnSCs transplantation in terms of pain
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Timepoint
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baseline, 1,3,6 and 9 months after hEnSCs injection
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Method of measurement
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self-reported of patients
2
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Description
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Safety and side effects of high dose hEnSCs transplantation in terms of hypersensivity
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Timepoint
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baseline, 1,3,6 and 9 months after hEnSCs injection
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Method of measurement
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clinical observation
3
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Description
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Safety of stem cell transplantation in terms of infection
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Timepoint
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baseline, 1,3,6 and 9 months after AT-MSCs injection
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Method of measurement
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CBC, LP
Secondary outcomes
1
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Description
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Severity of clinical scores
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Timepoint
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baseline, 1,3,6 and 9 months after hEnSCs transplantation
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Method of measurement
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clinical observation by neurologist
2
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Description
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assessment of neurological function
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Timepoint
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baseline, 1,3,6 and 9 months after After hEnSCs transplantation
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Method of measurement
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Magnetic resonance imaging (MRI)
3
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Description
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assessment of B cell markers CD19+CD20 percentage and MMP9 in peripheral blood of patients
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Timepoint
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baseline,1,3, 6 and 9 months after SCs transplantation
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Method of measurement
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Flowcytometery , eliza
Intervention groups
1
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Description
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Intervention group: endometrial Stem Cells in a amount of 5×106 MSC/Kg with Rituximab (500-1000mg i.v)
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Category
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Treatment - Drugs
2
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Description
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Control group: Rituximab (500-1000mg i.v) with placebo
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available