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Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment

Primary Purpose

Acute Spinal Cord Injury

Status
Unknown status
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
Laminectomy
Intradural space
Intrathecal
Intravenous
Sponsored by
Tri Phuoc Biotechnology., JSC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Spinal Cord Injury focused on measuring Acute Spinal cord Injury, Adipose derived stem cells

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vietnamese- German HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment with ADSCs transplantation

Treatment without ADSCs transplantation

Arm Description

4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous

Only intervention: laminectomy

Outcomes

Primary Outcome Measures

Number of Participants with adverse events after transplantation.
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.

Secondary Outcome Measures

Changes of spinal cord edema in the MRI at the lesion site
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.
Urinary and bowel function Improvement
Bladder pressure monitory to assess ability to feel and control urination and bowel.
Muscle contraction force measurement
Comparison the electromyography (EMG) score during contraction of given muscles before each injection and after transplantation 6 months, 12 months and 24 months.
Significant clinical improvement in ASIA impairment scale and general condition.
Patients are assess improvement level based on American Spinal Injury Assessment scale of A,B,C,D or E before and after transplantation.

Full Information

First Posted
January 6, 2014
Last Updated
January 10, 2014
Sponsor
Tri Phuoc Biotechnology., JSC
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1. Study Identification

Unique Protocol Identification Number
NCT02034669
Brief Title
Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment
Official Title
A Phase II Study of Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Completely Acute Spinal Cord Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tri Phuoc Biotechnology., JSC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Spinal Cord Injury
Keywords
Acute Spinal cord Injury, Adipose derived stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with ADSCs transplantation
Arm Type
Experimental
Arm Description
4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous
Arm Title
Treatment without ADSCs transplantation
Arm Type
No Intervention
Arm Description
Only intervention: laminectomy
Intervention Type
Device
Intervention Name(s)
Laminectomy
Intervention Description
surgical laminectomy with glial scar resection
Intervention Type
Device
Intervention Name(s)
Intradural space
Intervention Description
ADSCs injection into Intradural space at damage site
Intervention Type
Device
Intervention Name(s)
Intrathecal
Intervention Description
ADSCs Intrathecal into lumbar puncture
Intervention Type
Device
Intervention Name(s)
Intravenous
Intervention Description
ADSCs intravenous
Primary Outcome Measure Information:
Title
Number of Participants with adverse events after transplantation.
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Changes of spinal cord edema in the MRI at the lesion site
Description
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.
Time Frame
24 months
Title
Urinary and bowel function Improvement
Description
Bladder pressure monitory to assess ability to feel and control urination and bowel.
Time Frame
24 months
Title
Muscle contraction force measurement
Description
Comparison the electromyography (EMG) score during contraction of given muscles before each injection and after transplantation 6 months, 12 months and 24 months.
Time Frame
24 months
Title
Significant clinical improvement in ASIA impairment scale and general condition.
Description
Patients are assess improvement level based on American Spinal Injury Assessment scale of A,B,C,D or E before and after transplantation.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phuc Ba Duong, MD
Phone
+17143607716
Email
triphuocbio@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hoa D Nguyen, MD
Phone
+84904613833
Email
dinhhoaykhoa@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phuc Ba Duong, MD
Organizational Affiliation
Tri Phuoc Biotechnology., JSC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hoa D Nguyen, MD
Organizational Affiliation
Vietnamese- German Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vietnamese- German Hospital
City
Hanoi
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phuc Ba Duong, MD
Phone
+17143607716
Email
triphuocbio@gmail.com
First Name & Middle Initial & Last Name & Degree
Hoa D Nguyen, MSc, MD
Phone
+84904613833
Email
dinhhoaykhoa@yahoo.com

12. IPD Sharing Statement

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Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment

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