NCT02034669

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.

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

January 6, 2014

Last Update Submit

January 10, 2014

Conditions

Acute Spinal Cord Injury

Keywords

Acute Spinal cord Injury, Adipose derived stem cells

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 months

Secondary Outcomes (4)

  • Changes of spinal cord edema in the MRI at the lesion site

    24 months

  • Urinary and bowel function Improvement

    24 months

  • Muscle contraction force measurement

    24 months

  • Significant clinical improvement in ASIA impairment scale and general condition.

    24 months

Study Arms (2)

Treatment with ADSCs transplantation

EXPERIMENTAL

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

Device: LaminectomyDevice: Intradural spaceDevice: IntrathecalDevice: Intravenous

Treatment without ADSCs transplantation

NO INTERVENTION

Only intervention: laminectomy

Interventions

LaminectomyDEVICE

surgical laminectomy with glial scar resection

Treatment with ADSCs transplantation
Intradural spaceDEVICE

ADSCs injection into Intradural space at damage site

Treatment with ADSCs transplantation
IntrathecalDEVICE

ADSCs Intrathecal into lumbar puncture

Treatment with ADSCs transplantation
IntravenousDEVICE

ADSCs intravenous

Treatment with ADSCs transplantation

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 .
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vietnamese- German Hospital

Hanoi, Hanoi, Vietnam

RECRUITING

MeSH Terms

Interventions

LaminectomyInjections, Spinal

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, OperativeNeurosurgical ProceduresInjectionsDrug Administration RoutesDrug Therapy

Study Officials

  • Phuc Ba Duong, MD

    Tri Phuoc Biotechnology., JSC

    PRINCIPAL INVESTIGATOR

  • Hoa D Nguyen, MD

    Vietnamese- German Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phuc Ba Duong, MD

CONTACT

+17143607716triphuocbio@gmail.com

Hoa D Nguyen, MD

CONTACT

+84904613833dinhhoaykhoa@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 13, 2014

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations

VN(1)