- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01274975
Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury. (MSC)
Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy.
With the recent demonstration of MSC homing properties, intravenous aplications of MSCs to cell-damaged diseases have increased.
In a human clinical trial, eight male patients who had suffered a spinal cord injury were intravenously administered autologous hAdMSCs (4×10e8 cells) one time.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who understand and sign the consent form for this study.
- Age :19-60, males
- Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C)
- Duration of injury : > 2 months
Exclusion Criteria:
- Subjects who must put on a respirator
- Subjects who had malignant tumor within 5 years
- Subjects with a infectious disease include HIV and hepatitis
- Subjects who injured brain or spinal cord before spinal cord injury
- Subjects who has high body temperature more than 38℃ or acute disorder
- Subjects with anemia or thrombocytopenia
- Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
- Subjects with congenital or acquired immunodeficiency disorders
- Subjects with muscular dystrophy or articular rigidity
- Patients with clouded consciousness or speech disorder
- treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
- participating another clinical trials within 3 months
- other serious disease or disorder that could seriously affect ability to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety evaluation
Time Frame: 12weeks
|
Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected
|
12weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: SangHan Kim, MD, Anyang Sam Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Astrostem
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.
Clinical Trials on Spinal Cord Injury
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Taipei Veterans General Hospital, TaiwanThe Industrial Technology Research InstituteUnknownSpinal Cord Injuries | Complete Spinal Cord Injury | Incomplete Spinal Cord InjuryTaiwan
-
University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
-
Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
-
NervGen PharmaRecruitingSpinal Cord Injuries | Chronic Spinal Cord Injury | Subacute Spinal Cord InjuryUnited States
-
MetroHealth Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS); Case Western...RecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury CervicalUnited States
-
Kevin KilgoreNational Institute of Neurological Disorders and Stroke (NINDS); Case Western... and other collaboratorsRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury Cervical | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C5-C7 Level With Incomplete LesionUnited States
-
The University of Texas Health Science Center,...TerminatedSpinal Cord Injuries | Cervical Spinal Cord Injury | Traumatic Spinal Cord CompressionUnited States
-
StemCells, Inc.TerminatedStudy of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord InjuryCervical Spinal Cord Injury | Spine Injury | Cervical Spine InjuryUnited States, Canada
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S.Biomedics Co., Ltd.Yonsei University; Linical Co., Ltd.RecruitingSpinal Cord Injury, Acute | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C4 Level With Complete LesionKorea, Republic of
-
Mahidol UniversityRecruitingSpinal Cord Injury | Incomplete Spinal Cord InjuryThailand
Clinical Trials on Autologous Adipose Derived Mesenchymal Stem Cells
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Mohamad BydonCompletedParalysis | Spinal Cord InjuriesUnited States
-
The Foundation for Orthopaedics and Regenerative...SuspendedSpinal Cord InjuriesGreece
-
National Yang Ming UniversityCompletedThe Sequelae Caused by Severe Brain InjuryTaiwan
-
The Foundation for Orthopaedics and Regenerative...Suspended
-
Institute of Biophysics and Cell Engineering of...Belarusian State Medical UniversityCompleted
-
Andalusian Initiative for Advanced Therapies -...Iniciativa Andaluza en Terapias AvanzadasCompletedDiabetes | Critical Limb Ischemia (CLI)Spain
-
Mayo ClinicRegenerative Medicine MinnesotaTerminatedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type 1 | Diabetic Kidney Disease | Diabetic Nephropathies | Chronic Kidney Disease | Kidney Failure | Diabetic Nephropathy Type 2 | Kidney InsufficiencyUnited States
-
R-BioNot yet recruitingKnee Arthritis | Degenerative Arthritis
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Bukwang PharmaceuticalCompletedSpinal Cord InjuryKorea, Republic of
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R-BioCompleted