- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02034669
Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment
A Phase II Study of Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Completely Acute Spinal Cord Injury.
This study is designed to assess the safety and effect of autologous adipose derived stem cell (ADSCs) transplantation in acute spinal cord injury patients.
- To assess the safety of autologous ADSCs transplantation in acute spinal cord injury and the complication after ADSCs transplantation.
- To evaluate the effect of ADSCs isolation and expansion procedure.
- To determine if functional outcome is improved following ADSCs transplantation in acute spinal cord injury patient, using pre-transplantation spinal cord function as the control.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research has carried out in Phase II which is designed as randomized controlled trials.
Selection of patients began in Feb,2013, 48 patients are divided in two group according to a 2:1 ratio (the number of candidates as treated: the candidates as control).
The effectiveness of preliminary trial are evaluated by assessing Frankel/ASIA motor grade, measuring electrophysiological parameters, enhanced MRI and urinary and bowel function.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Phuc Ba Duong, MD
- Phone Number: +17143607716
- Email: triphuocbio@gmail.com
Study Contact Backup
- Name: Hoa D Nguyen, MD
- Phone Number: +84904613833
- Email: dinhhoaykhoa@yahoo.com
Study Locations
-
-
-
Hanoi, Vietnam
- Recruiting
- Vietnamese- German Hospital
-
Contact:
- Phuc Ba Duong, MD
- Phone Number: +17143607716
- Email: triphuocbio@gmail.com
-
Contact:
- Hoa D Nguyen, MSc, MD
- Phone Number: +84904613833
- Email: dinhhoaykhoa@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be able to give voluntary (patients may not be able to write) consent.
- Must be able to understand study information provided to him.
- Patients with complete spinal cord < 2 weeks in acute category
- The level of spinal cord injury must be categorized at A level in terms of ASIA Impairment scale.
- Age should be between 19-60 years
- Both male and female
Exclusion Criteria:
- Support respiration by machine
- Melanoma within 5 years
- Infectious diseases including HIV and Hepatitis B, C
- Brain damage or multiple trauma
- Body temperature higher 38 ℃ or acute disorder
- Anemia or thrombocytopenia
- Angina , myocardial infarction , heart disease , embolic disease , chronic renal failure, glomerular disease and chronic obstructive pulmonary disease.
- Congenital or acquired immunodeficiency disorder
- Muscular dystrophy or muscle stiffness
- Non-conscious or voice disorders
- Treatment with cytotoxic drugs ( immunosuppressive drugs , corticosteroids and cytotoxic drugs) during the clinical trials .
- Participating in another clinical trial within 3 months
- Other serious disease or disorder can seriously affect the ability to participate in research.
- Women who are pregnant or lactating .
- Allergy to antibiotics and anesthetics .
- Do not agree to participate in research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment with ADSCs transplantation
4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous
|
surgical laminectomy with glial scar resection
ADSCs injection into Intradural space at damage site
ADSCs Intrathecal into lumbar puncture
ADSCs intravenous
|
NO_INTERVENTION: Treatment without ADSCs transplantation
Only intervention: laminectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with adverse events after transplantation.
Time Frame: 24 months
|
Number of Participants with adverse events is as a measure of safety and tolerability after ADSC transplantation.
Adverse events can be impaired liver and kidney, immunosuppression or immune deficiency, hypersensitivity, anaphylactic shock, meningitis symptoms, etc.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of spinal cord edema in the MRI at the lesion site
Time Frame: 24 months
|
Patients take MRI at the lesion site before each injection and after transplantation 6 months, 12 months, 24 months.
MRI at the lesion site shows spinal cord edema level is reduced or not.
|
24 months
|
Urinary and bowel function Improvement
Time Frame: 24 months
|
Bladder pressure monitory to assess ability to feel and control urination and bowel.
|
24 months
|
Muscle contraction force measurement
Time Frame: 24 months
|
Comparison the electromyography (EMG) score during contraction of given muscles before each injection and after transplantation 6 months, 12 months and 24 months.
|
24 months
|
Significant clinical improvement in ASIA impairment scale and general condition.
Time Frame: 24 months
|
Patients are assess improvement level based on American Spinal Injury Assessment scale of A,B,C,D or E before and after transplantation.
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Phuc Ba Duong, MD, Tri Phuoc Biotechnology., JSC
- Principal Investigator: Hoa D Nguyen, MD, Vietnamese- German Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
- TP-VD-2012
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 Acute Spinal Cord Injury
-
University of British ColumbiaRecruitingSpinal Cord Injuries | Acute Spinal Cord Injury | Acute Spinal Paralysis | Trauma, Spinal CordCanada
-
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
-
Kringle Pharma, Inc.Recruiting
-
AlaMab Therapeutics (Shanghai) Inc.RecruitingAcute Spinal Cord InjuryChina
-
University of KentuckyRecruiting
-
University of British ColumbiaUnited States Department of DefenseRecruitingSpinal Cord Injuries | Acute Spinal Cord InjuryCanada
-
Pharmazz, Inc.Recruiting
-
Ohio State UniversityTerminated
-
Chinese Academy of SciencesThe First Affiliated Hospital of Soochow University; General Hospital of Ningxia... and other collaboratorsUnknownAcute Spinal Cord InjuryChina
-
University of CalgaryHotchkiss Brain Institute, University of Calgary; AANS/CNS Section on Disorders...TerminatedAcute Spinal Cord InjuryUnited States, Canada
Clinical Trials on Laminectomy
-
Assiut UniversityNot yet recruitingLumbar Spinal Stenosis
-
Assiut UniversityActive, not recruitingCervical Spinal Cord InjuryEgypt
-
Greenwich HospitalCompleted
-
Sohag UniversityNot yet recruitingDegenerative Cervical Myelopathy (DCM)
-
University of PittsburghWithdrawnSpinal Stenosis | Degenerative Spondylolisthesis
-
Uppsala University HospitalKarolinska Institutet; Linkoeping University; Sahlgrenska University Hospital...RecruitingCervical Spondylotic MyelopathySweden
-
Peking University Third HospitalNot yet recruiting
-
Uppsala UniversityCompletedSpinal Stenosis | Spinal Stenosis Lumbar | Degeneration Spine | Degeneration Lumbar Spine | Neurogenic Claudication Co-Occurrent and Due to Spinal Stenosis of Lumbar Region | Pseudoclaudication SyndromeSweden
-
St. Olavs HospitalNorwegian University of Science and TechnologyCompletedSpinal Stenosis | Spinal Cord CompressionNorway
-
International Stemcell Services LimitedCompletedSpinal Cord InjuriesIndia