Spinal Cord InjuryPhase 1/2NCT02688049
NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair
A Phase 1/2 study testing NeuroRegen scaffold/mesenchymal stem cells transplantation and NeuroRegen scaffold/neural stem cells transplantation in people with Spinal Cord Injury, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- NeuroRegen scaffold/mesenchymal stem cells transplantation and NeuroRegen scaffold/neural stem cells transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-65 years old.
- Completely spinal cord injury at the cervical and thoracic level (C5-T12).
- Classification ASIA A with no significant further improvement.
- Patients signed informed consent.
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Who cannot join
- A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease).
- Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
- History of life threatening allergic or immune-mediated reaction.
- Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
- History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
- Severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
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- Lactating and pregnant woman.
- Alcohol drug abuse /dependence.
- Participated in any other clinical trials within 3 months before the enrollment.
- A drug or treatment known to cause effect on the central nervous system during the past four weeks.
- A drug or treatment known to cause major organ system toxicity during the past four weeks.
- Poor compliance, difficult to complete the study.
- Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of NeuroRegen Scaffold™ Combined With Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair
The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury.
- Conditions
- Spinal Cord Injury
- Being tested
- NeuroRegen scaffold/mesenchymal stem cells transplantation, NeuroRegen scaffold/neural stem cells transplantation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroRegen scaffold/mesenchymal stem cells transplantationBiological
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million mesenchymal stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
NeuroRegen scaffold/neural stem cells transplantationBiological
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million neural stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
| Study group | Role | What they receive |
|---|---|---|
| NeuroRegen scaffold/mesenchymal stem cells transplantation | Experimental | Patients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury. Receives: Biological: NeuroRegen scaffold/mesenchymal stem cells transplantation |
| NeuroRegen scaffold/neural stem cells transplantation | Experimental | Patients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury. Receives: Biological: NeuroRegen scaffold/neural stem cells transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in ASIA (American Spinal Injury Association) Impairment Scale
Measured: 24 months
Improvements in Somatosensory Evoked Potentials (SSEP)
Measured: 24 months
Improvements in Motor Evoked Potentials (MEP)
Measured: 24 months
Secondary outcomes (4)
Improvements in Independence Measures
Functional Independence Measure (FIM) will be assessed before and after surgery.
Measured: 1, 3, 6, 12, 18 and 24 months
Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI)
The MRI at the transplantation site will be assessed before and after transplantation.
Measured: 1, 3, 6, 12, 18 and 24 months
Improvements in Urinary and Bowel Function
The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after surgery.
Measured: 1, 3, 6, 12, 18 and 24 months
Safety and Tolerability assessed by Adverse Events
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Affiliated Hospital of Logistics University of CAPF
- Responsible party
- Principal investigator, Jianwu Dai, Chinese Academy of Sciences
- Investigators
- Jianwu Dai, Ph.D, Principal investigator, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688049
- Sponsor's protocol ID
- CAS-XDA-MNSCI/IGDB
- Status last verified
- Feb 2016
- First submitted
- 6 Feb 2016
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of NeuroRegen Scaffold™ Combined With Mesenchymal Stem Cells or Neural Stem Cells for Chronic Spinal Cord Injury Repair
- ClinicalTrials.gov ID
- NCT02688049
- Acronym / sponsor ID
- CAS-XDA-MNSCI/IGDB
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Affiliated Hospital of Logistics University of CAPF
- Study start
- Jan 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Feb 2016 (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.
The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroRegen scaffold/mesenchymal stem cells transplantation | Experimental | Biological: NeuroRegen scaffold/mesenchymal stem cells transplantationPatients receive NeuroRegen scaffold with mesenchymal stem cells transplantation after spinal cord injury. |
| NeuroRegen scaffold/neural stem cells transplantation | Experimental | Biological: NeuroRegen scaffold/neural stem cells transplantationPatients receive NeuroRegen scaffold with neural stem cells transplantation after spinal cord injury. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18-65 years old.
- Completely spinal cord injury at the cervical and thoracic level (C5-T12).
- Classification ASIA A with no significant further improvement.
- Patients signed informed consent.
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Key exclusion criteria (13 listed)
- A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease).
- Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
- History of life threatening allergic or immune-mediated reaction.
- Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
- History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
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 |
|---|---|---|
| NeuroRegen scaffold/mesenchymal stem cells transplantationPatients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million mesenchymal stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures. | Biological | NeuroRegen scaffold/mesenchymal stem cells transplantation |
| NeuroRegen scaffold/neural stem cells transplantationPatients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million neural stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures. | Biological | NeuroRegen scaffold/neural stem cells transplantation |
Primary outcome
Improvements in ASIA (American Spinal Injury Association) Impairment Scale
Time frame: 24 months
Improvements in Somatosensory Evoked Potentials (SSEP)
Time frame: 24 months
Improvements in Motor Evoked Potentials (MEP)
Time frame: 24 months
4 secondary outcomes
Improvements in Independence Measures
Time frame: 1, 3, 6, 12, 18 and 24 months
Changes at the transplantation site in spinal cord by Magnetic Resonance Imaging (MRI)
Time frame: 1, 3, 6, 12, 18 and 24 months
Improvements in Urinary and Bowel Function
Time frame: 1, 3, 6, 12, 18 and 24 months
Safety and Tolerability assessed by Adverse Events
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
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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.
Jianwu Dai, Ph.D principal investigator
Chinese Academy of Sciences
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 NeuroRegen scaffold/mesenchymal stem cells transplantation and NeuroRegen scaffold/neural stem cells transplantation in people with Spinal Cord Injury, run by Chinese Academy of Sciences at 1 site in China.
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 5 inclusion and 13 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 23 Dec 2020. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvements in ASIA (American Spinal Injury Association) Impairment Scale (time frame: 24 months). The study lists 3 primary outcomes in all. 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 23 Dec 2020.