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

January 10, 2014 updated by: Tri Phuoc Biotechnology., JSC

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.

  1. To assess the safety of autologous ADSCs transplantation in acute spinal cord injury and the complication after ADSCs transplantation.
  2. To evaluate the effect of ADSCs isolation and expansion procedure.
  3. 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

Unknown

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

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Device: Laminectomy
surgical laminectomy with glial scar resection
Device: Intradural space
ADSCs injection into Intradural space at damage site
Device: Intrathecal
ADSCs Intrathecal into lumbar puncture
Device: Intravenous
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

This is where you will find people and organizations involved with this study.

Sponsor

Tri Phuoc Biotechnology., JSC

Investigators

  • Principal Investigator: Phuc Ba Duong, MD, Tri Phuoc Biotechnology., JSC
  • Principal Investigator: Hoa D Nguyen, MD, Vietnamese- German Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (ESTIMATE)

January 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

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.

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