Spinal Cord InjuryPhase 1/2NCT02688062
NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in SCI
A Phase 1/2 study testing NeuroRegen Scaffold with BMMCs transplantation and Surgical intradural decompression and adhesiolysis 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 investigate the efficacy and safety of NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and complete spinal cord injury, compared to the treatment of surgical intradural decompression and adhesiolysis only. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- NeuroRegen Scaffold with BMMCs transplantation and Surgical intradural decompression and adhesiolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Completely spinal cord injury at the thoracic level as assessed by magnetic resonance imaging (MRI) and electrophysiology.
- ASIA Impairment Scale (AIS) grade A.
- Male or female, 18-60 years old.
- No significant further improvement after injury and rehabilitation.
- Patients with normal peripheral nerve function and without muscle atrophy.
- Cardiovascular, respiratory, liver, kidney functions and laboratory examinations are within normal ranges.
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- No brain disease or mental disorder.
- Ability and willingness to regular visit to hospital and follow up during the protocol procedures.
- Patients signed informed consent.
Who cannot join
- A current diagnosis of any primary diseases affecting limb functions (e.g., traumatic brain injury, cerebral hemorrhage, cognitive disorders or other central nervous system diseases).
- Patients without any rehabilitation train after injury.
- Remarkable muscle atrophy or fibrosis.
- Degeneration of peripheral nerve function.
- Allergic constitution.
- Participation in any immunomodulator therapy or experimental drug treatment within 60 days prior to study.
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- Suffering diabetes, autoimmune diseases, tumor or severe hypertension.
- Patients with severe heart, lung, liver or renal dysfunction are unable to meet the surgery standards.
- Severe bleeding tendency or abnormal coagulation function.
- Inflammation or skin ulcers at the surgical site.
- Lactating and pregnant woman.
- 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: NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in Patients With Chronic Spinal Cord Injury
The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and complete spinal cord injury, compared to the treatment of surgical intradural decompression and adhesiolysis only.
- Conditions
- Spinal Cord Injury
- Being tested
- NeuroRegen Scaffold with BMMCs transplantation, Surgical intradural decompression and adhesiolysis
- 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 with BMMCs transplantationBiological
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Surgical intradural decompression and adhesiolysisProcedure or surgery
Patients with chronic SCI (ASIA grade A) will receive intradural decompression and adhesiolysis surgery and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
| Study group | Role | What they receive |
|---|---|---|
| NeuroRegen Scaffold with BMMCs transplantation | Experimental | Not described Receives: Biological: NeuroRegen Scaffold with BMMCs transplantation |
| Surgical intradural decompression and adhesiolysis | Experimental | Not described Receives: Procedure: Surgical intradural decompression and adhesiolysis |
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
Magnetic Resonance Imaging (MRI)
The change of treated spinal cord injury will be assessed by Magnetic Resonance Imaging (MRI) before and after surgery.
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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- First Hospitals affiliated to the China PLA General Hospital
- 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
- NCT02688062
- Sponsor's protocol ID
- CAS-XDA-SDSCI/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
- NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in Patients With Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02688062
- Acronym / sponsor ID
- CAS-XDA-SDSCI/IGDB
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- First Hospitals affiliated to the China PLA General Hospital
- 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 investigate the efficacy and safety of NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and complete spinal cord injury, compared to the treatment of surgical intradural decompression and adhesiolysis only.
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 with BMMCs transplantation | Experimental | Biological: NeuroRegen Scaffold with BMMCs transplantation |
| Surgical intradural decompression and adhesiolysis | Experimental | Procedure: Surgical intradural decompression and adhesiolysis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Completely spinal cord injury at the thoracic level as assessed by magnetic resonance imaging (MRI) and electrophysiology.
- ASIA Impairment Scale (AIS) grade A.
- Male or female, 18-60 years old.
- No significant further improvement after injury and rehabilitation.
- Patients with normal peripheral nerve function and without muscle atrophy.
Key exclusion criteria (13 listed)
- A current diagnosis of any primary diseases affecting limb functions (e.g., traumatic brain injury, cerebral hemorrhage, cognitive disorders or other central nervous system diseases).
- Patients without any rehabilitation train after injury.
- Remarkable muscle atrophy or fibrosis.
- Degeneration of peripheral nerve function.
- Allergic constitution.
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 with BMMCs transplantationPatients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures. | Biological | NeuroRegen Scaffold with BMMCs transplantation |
| Surgical intradural decompression and adhesiolysisPatients with chronic SCI (ASIA grade A) will receive intradural decompression and adhesiolysis surgery and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures. | Procedure or surgery | Surgical intradural decompression and adhesiolysis |
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
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 with BMMCs transplantation and Surgical intradural decompression and adhesiolysis 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 9 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.