Spinal Cord InjuryPhase 1/2NCT03966794
Functional Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
A Phase 1/2 study testing Epidural Electrical Stimulation and Functional scaffold & Epidural Electrical Stimulation in people with Spinal Cord Injury, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
The study is designed to assess the role of functional neural regeneration collagen scaffold transplantation combined with epidural electrical stimulation in spinal cord injury patients. 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?
- Epidural Electrical Stimulation and Functional scaffold & Epidural Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 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
- The enrolled participants are divided into three categories:
- Participants had complete functional scaffold transplantation in previous study and had motor functional recovery
- Participants With Acute Complete SCI: (1) Classification ASIA A, occurring within past 14 days; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) No serious complications
- Participants With Chronic Complete SCI: (1) Classification ASIA A, greater than 6 months post injury and no significant further improvement within past 3 months; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) Peripheral nervous system in good condition; (4) No serious complications
- Men or non-pregnant women, 18-60 years old
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures
- Accompanied by a family member
- Signed informed consent
Who cannot join
- Obvious muscle atrophy or fibrosis
- Decline in peripheral nerve function
- A current diagnosis of diseases affecting spinal cord injury recovery or rehabilitation training (e.g., brain injury, cerebral hemorrhage, cognitive impairment, other central nervous system diseases)
- Having serious health problems, (e.g., cardiovascular disease, diabetes, autoimmune diseases, tumors or severe hypertension) or serious complications (e.g. severe bedsores, pulmonary infection, respiratory disorders)
- Pregnancy or lactation
- History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders
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- No family member accompany or can not get in touch with family members
- Poor compliance, difficult to complete the study
- Any other conditions that might increase the risk of participants or interfere with the clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, 300162
Fengwu Tang
Shixiang Cheng, shixiangcheng@vip.126.com
About this study
Official title: Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
The study is designed to assess the role of functional neural regeneration collagen scaffold transplantation combined with epidural electrical stimulation in spinal cord injury patients.
- Conditions
- Spinal Cord Injury
- Being tested
- Epidural Electrical Stimulation, Functional scaffold & Epidural Electrical Stimulation
- 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.
Epidural Electrical StimulationDevice
Participants had finished the previous clinical trial with functional neural regeneration collagen scaffold transplantation, and will receive epidural electrical stimulation of the spinal cord in this group.
Functional scaffold & Epidural Electrical StimulationCombination product
Participants with acute complete SCI or chronic complete SCI will receive functional neural regeneration scaffold transplantation and epidural electrical stimulation of the spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Electrical Stimulation | Experimental | Not described Receives: Device: Epidural Electrical Stimulation |
| Functional scaffold & Epidural Electrical Stimulation | Experimental | Not described Receives: Combination Product: Functional scaffold & Epidural Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Change in ASIA Impairment Scale
American Spinal Injury Association Impairment Scale of A, B, C, D or E will be assessed before and after transplantation.
Measured: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Secondary outcomes (7)
Change in ASIA motor score
Measured: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Functional Independence Measure (FIM)
Measured: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Somatosensory Evoked Potentials (SSEP) monitoring
Measured: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Motor Evoked Potentials (MEP) monitoring
Measured: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)
Measured: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Walking Speed
Measured: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Stride length
Measured: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Aug 2019
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT03966794
- Sponsor's protocol ID
- CAS-XDA-EESCI/IGDB
- Status last verified
- May 2019
- First submitted
- 23 May 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair
- ClinicalTrials.gov ID
- NCT03966794
- Acronym / sponsor ID
- CAS-XDA-EESCI/IGDB
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Affiliated Hospital of Logistics University of CAPF
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 May 2019 (actual)
- 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 study is designed to assess the role of functional neural regeneration collagen scaffold transplantation combined with epidural electrical stimulation in spinal cord injury patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Electrical Stimulation | Experimental | Device: Epidural Electrical Stimulation |
| Functional scaffold & Epidural Electrical Stimulation | Experimental | Combination Product: Functional scaffold & Epidural Electrical Stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants had complete functional scaffold transplantation in previous study and had motor functional recovery
- Participants With Acute Complete SCI: (1) Classification ASIA A, occurring within past 14 days; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) No serious complications
- Participants With Chronic Complete SCI: (1) Classification ASIA A, greater than 6 months post injury and no significant further improvement within past 3 months; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) Peripheral nervous system in good condition; (4) No serious complications
- Men or non-pregnant women, 18-60 years old
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures
Key exclusion criteria (9 listed)
- Obvious muscle atrophy or fibrosis
- Decline in peripheral nerve function
- A current diagnosis of diseases affecting spinal cord injury recovery or rehabilitation training (e.g., brain injury, cerebral hemorrhage, cognitive impairment, other central nervous system diseases)
- Having serious health problems, (e.g., cardiovascular disease, diabetes, autoimmune diseases, tumors or severe hypertension) or serious complications (e.g. severe bedsores, pulmonary infection, respiratory disorders)
- Pregnancy or lactation
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 |
|---|---|---|
| Epidural Electrical StimulationParticipants had finished the previous clinical trial with functional neural regeneration collagen scaffold transplantation, and will receive epidural electrical stimulation of the spinal cord in this group. | Device | Epidural Electrical Stimulation |
| Functional scaffold & Epidural Electrical StimulationParticipants with acute complete SCI or chronic complete SCI will receive functional neural regeneration scaffold transplantation and epidural electrical stimulation of the spinal cord. | Combination product | Functional scaffold & Epidural Electrical Stimulation |
Primary outcome
Safety and Tolerability assessed by Adverse Events
Time frame: Up to 6 months
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up
Change in ASIA Impairment Scale
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
American Spinal Injury Association Impairment Scale of A, B, C, D or E will be assessed before and after transplantation.
7 secondary outcomes
Change in ASIA motor score
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Functional Independence Measure (FIM)
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Somatosensory Evoked Potentials (SSEP) monitoring
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Motor Evoked Potentials (MEP) monitoring
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Changes at the Transplantation Site in Spinal Cord by Magnetic Resonance Imaging (MRI)
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Walking Speed
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Change in Stride length
Time frame: Baseline, 1, 3 , 6, 12 and 24 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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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 Epidural Electrical Stimulation and Functional scaffold & Epidural Electrical Stimulation 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 8 inclusion and 9 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 1 Nov 2019. 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?
Contact Guang Han (86-22-60577133, hanguang2006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability assessed by Adverse Events (time frame: Up to 6 months). The study lists 2 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 1 Nov 2019.