Acute Spinal Cord InjuryPhase 1/2NCT02034669
Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment
A Phase 1/2 study testing Laminectomy, Intradural space and Intrathecal in people with Acute Spinal Cord Injury, run by Tri Phuoc Biotechnology., JSC at 1 site in Vietnam.
Trial 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. To assess the safety of autologous ADSCs transplantation in acute spinal cord injury and the complication after ADSCs transplantation. 2. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- Laminectomy, Intradural space and Intrathecal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteVietnam
- Study dates
- Feb 2013to Mar 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Vietnamese- German Hospital
Hanoi, Hanoi
Phuc Ba Duong, MD, +17143607716, triphuocbio@gmail.com
Hoa D Nguyen, MSc, MD, +84904613833, dinhhoaykhoa@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- Laminectomy, Intradural space, Intrathecal, Intravenous
- Keywords
- Acute Spinal cord Injury, Adipose derived stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaminectomyDevice
surgical laminectomy with glial scar resection
Intradural spaceDevice
ADSCs injection into Intradural space at damage site
IntrathecalDevice
ADSCs Intrathecal into lumbar puncture
IntravenousDevice
ADSCs intravenous
| Study group | Role | What they receive |
|---|---|---|
| Treatment with ADSCs transplantation | Experimental | 4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous Receives: Device: Laminectomy; Device: Intradural space; Device: Intrathecal; Device: Intravenous |
| Treatment without ADSCs transplantation | No intervention | Only intervention: laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
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.
Measured: 24 months
Urinary and bowel function Improvement
Bladder pressure monitory to assess ability to feel and control urination and bowel.
Measured: 24 months
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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri Phuoc Biotechnology., JSC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phuc Ba Duong, MD, Principal investigator, Tri Phuoc Biotechnology., JSCHoa D Nguyen, MD, Principal investigator, Vietnamese- German Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034669
- Sponsor's protocol ID
- TP-VD-2012
- Status last verified
- Jan 2014
- First submitted
- 6 Jan 2014
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Completely Acute Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT02034669
- Acronym / sponsor ID
- TP-VD-2012
- Conditions
- Acute Spinal Cord Injury
- Keywords
- Acute Spinal cord Injury, Adipose derived stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tri Phuoc Biotechnology., JSCUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with ADSCs transplantation | Experimental | Device: Laminectomy, Device: Intradural space, Device: Intrathecal, Device: Intravenous4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous |
| Treatment without ADSCs transplantation | No intervention | –Only intervention: laminectomy |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laminectomysurgical laminectomy with glial scar resection | Device | Treatment with ADSCs transplantation |
| Intradural spaceADSCs injection into Intradural space at damage site | Device | Treatment with ADSCs transplantation |
| IntrathecalADSCs Intrathecal into lumbar puncture | Device | Treatment with ADSCs transplantation |
| IntravenousADSCs intravenous | Device | Treatment with ADSCs transplantation |
Primary outcome
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.
4 secondary outcomes
Changes of spinal cord edema in the MRI at the lesion site
Time frame: 24 months
Urinary and bowel function Improvement
Time frame: 24 months
Muscle contraction force measurement
Time frame: 24 months
Significant clinical improvement in ASIA impairment scale and general condition.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phuc Ba Duong, MD principal investigator
Tri Phuoc Biotechnology., JSC
Hoa D Nguyen, MD principal investigator
Vietnamese- German Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Laminectomy, Intradural space and Intrathecal in people with Acute Spinal Cord Injury, run by Tri Phuoc Biotechnology., JSC at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phuc Ba Duong, MD (+17143607716, triphuocbio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with adverse events after transplantation. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014.