Acute Spinal Cord InjuryPhase 1NCT02510365
Functional Neural Regeneration Collagen Scaffold Transplantation in Acute Spinal Cord Injury Patients
A Phase 1 study testing Functional collagen scaffold in people with Acute Spinal Cord Injury, run by Chinese Academy of Sciences at 5 sites in China.
Trial summary
The study is designed to assess the safety and efficacy of functional neural regeneration collagen scaffold transplanted into acute spinal cord injury patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- Functional collagen scaffold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesChina
- Study dates
- Apr 2015to Dec 2021
- Phase
- Phase 1
- 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 (C4-T12).
- Classification ASIA A, occurring within past 21 days.
- 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
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
First Hospitals affiliated to the China PLA General Hospital
Beijing, 100037
Shuxun Hou, 86-10-66867350, hsxortho@hotmail.com
Jiaguang Tang, Ph.D, 86-10-6684837, jiaguangtang@yahoo.com.cn
- Recruiting
Xinqiao Hospital of Army Medical University
Chongqing, 400037
Tongwei Chu, chutw@sina.com
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, 215006
Huilin Yang, Ph.D
Qin Shi, Ph.D, 86-512-67781169, qshisz@gmail.com
- Recruiting
Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, 300162
Sai Zhang, M.D, 86-22-60577101
Shixiang Cheng, 86-22-60577171, shixiangcheng@vip.126.com
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, 750004
Hechun Xia
Xueyun Liang, nxmclxy@163.com
About this study
Official title: Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation in Complete (AISA) Acute Spinal Cord Injury Patients
The study is designed to assess the safety and efficacy of functional neural regeneration collagen scaffold transplanted into acute spinal cord injury patients.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- Functional collagen scaffold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional collagen scaffoldBiological
Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Functional collagen scaffold | Experimental | Functional neural regeneration collagen scaffold transplantation. Receives: Biological: Functional collagen scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation Number of patients with adverse events
Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold transplantation.
Measured: 6 months
Secondary outcomes (3)
Improvements in ASIA Impairment Scale
American Spinal Injury Assessment Scale of A, B, C, D or E will be assessed before and after transplantation.
Measured: 12 months
Improvements in Electrophysiological monitoring
Somatosensory Evoked Potentials (SSEP) monitoring will be assessed before and after transplantation.
Measured: 12 months
Improvements in Electrophysiological monitoring
Motor Evoked Potentials (MEP) monitoring will be assessed before and after transplantation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startApr 2015
- 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Affiliated Hospital of Logistics University of CAPF, The First Affiliated Hospital of Soochow University, First Hospitals affiliated to the China PLA General Hospital, General Hospital of Ningxia Medical University, Army Medical University, China
- Responsible party
- Principal investigator, Jianwu Dai, Chinese Academy of Sciences
- Investigators
- Jianwu Dai, Ph.D, Principal investigator, Chinese Academy of SciencesSai Zhang, M.D, Study chair, Affiliated Hospital of Logistics Universtiy of CAPFHuilin Yang, Ph.D, Study chair, The First Affiliated Hospital of Soochow UniversityShuxun Hou, Study chair, First Hospitals affiliated to the China PLA General HospitalHechun Xia, Study chair, General Hospital of Ningxia Medical UniversityTongwei Chu, Study chair, Army Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510365
- Sponsor's protocol ID
- CAS-XDA-ACSCI/IGDB
- Status last verified
- Jul 2015
- First submitted
- 26 Jul 2015
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen W, Zhang Y, Yang S, Sun J, Qiu H, Hu X, Niu X, Xiao Z, Zhao Y, Zhou Y, Dai J, Chu T. NeuroRegen Scaffolds Combined with Autologous Bone Marrow Mononuclear Cells for the Repair of Acute Complete Spinal Cord Injury: A 3-Year Clinical Study. Cell Transplant. 2020 Jan-Dec;29:963689720950637. doi: 10.1177/0963689720950637.
PubMed 32862715Xiao Z, Tang F, Zhao Y, Han G, Yin N, Li X, Chen B, Han S, Jiang X, Yun C, Zhao C, Cheng S, Zhang S, Dai J. Significant Improvement of Acute Complete Spinal Cord Injury Patients Diagnosed by a Combined Criteria Implanted with NeuroRegen Scaffolds and Mesenchymal Stem Cells. Cell Transplant. 2018 Jun;27(6):907-915. doi: 10.1177/0963689718766279. Epub 2018 Jun 5.
PubMed 29871514
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
- Safety and Efficacy of Functional Neural Regeneration Collagen Scaffold Transplantation in Complete (AISA) Acute Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT02510365
- Acronym / sponsor ID
- CAS-XDA-ACSCI/IGDB
- Conditions
- Acute Spinal Cord Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Affiliated Hospital of Logistics University of CAPF, The First Affiliated Hospital of Soochow University, First Hospitals affiliated to the China PLA General Hospital, General Hospital of Ningxia Medical University, Army Medical University, China
- Study start
- Apr 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Jul 2015 (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 study is designed to assess the safety and efficacy of functional neural regeneration collagen scaffold transplanted into acute spinal cord injury patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional collagen scaffold | Experimental | Biological: Functional collagen scaffoldFunctional neural regeneration collagen scaffold transplantation. |
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 (C4-T12).
- Classification ASIA A, occurring within past 21 days.
- 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 |
|---|---|---|
| Functional collagen scaffoldPatients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery. | Biological | Functional collagen scaffold |
Primary outcome
Safety Evaluation Number of patients with adverse events
Time frame: 6 months
Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold transplantation.
3 secondary outcomes
Improvements in ASIA Impairment Scale
Time frame: 12 months
Improvements in Electrophysiological monitoring
Time frame: 12 months
Improvements in Electrophysiological monitoring
Time frame: 12 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.
- Derived from this study: PubMed 32862715Chen W, Zhang Y, Yang S, Sun J, Qiu H, Hu X, Niu X, Xiao Z, Zhao Y, Zhou Y, Dai J, Chu T. NeuroRegen Scaffolds Combined with Autologous Bone Marrow Mononuclear Cells for the Repair of Acute Complete Spinal Cord Injury: A 3-Year Clinical Study. Cell Transplant. 2020 Jan-Dec;29:963689720950637. doi: 10.1177/0963689720950637.
- Derived from this study: PubMed 29871514Xiao Z, Tang F, Zhao Y, Han G, Yin N, Li X, Chen B, Han S, Jiang X, Yun C, Zhao C, Cheng S, Zhang S, Dai J. Significant Improvement of Acute Complete Spinal Cord Injury Patients Diagnosed by a Combined Criteria Implanted with NeuroRegen Scaffolds and Mesenchymal Stem Cells. Cell Transplant. 2018 Jun;27(6):907-915. doi: 10.1177/0963689718766279. Epub 2018 Jun 5.
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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
Sai Zhang, M.D study chair
Affiliated Hospital of Logistics Universtiy of CAPF
Huilin Yang, Ph.D study chair
The First Affiliated Hospital of Soochow University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Functional collagen scaffold in people with Acute Spinal Cord Injury, run by Chinese Academy of Sciences at 5 sites 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 5 sites 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 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.
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 Zhifeng Xiao, Ph.D (86-10-82614420, zfxiao@genetics.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation Number of patients with adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02510365, which also lists 2 linked publications.
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.