Brain InjuryPhase 1NCT02767817
Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury
A Phase 1 study testing Stereotactic Hematoma Evacuation, MSCs Transplantation and Injectable Collagen Scaffold with MSCs Transplantation in people with Brain Injury, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain injury. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Brain Injury
- What is being tested?
- Stereotactic Hematoma Evacuation, MSCs Transplantation and Injectable Collagen Scaffold with MSCs Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female，35-75 years old.
- The surgery time should be > 6 hours after symptom onset.
- Glasgow coma score (GCS) was 9-15.
- CT diagnosis of intracerebral hemorrhage (25-40 ml), except for patients with signs of craniotomy to remove the hematoma.
- Signed informed consent obtained from the patient or patient's legally authorized representative.
Who cannot join
- Glasgow coma scale of <8.
- Patients suffering severe heart failure, severe lung disease, uremia, cirrhosis, end-stage cancer, coagulation disorders, stroke sequela.
- Asphyxia, cardiac arrest or successful cardiopulmonary resuscitation before hospitalization.
- Lactating or pregnant woman.
- Refuse to sign informed content.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Mesenchymal Stem Cells Transplantation in Patients With Brain Injury
The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain injury.
- Conditions
- Brain Injury
- Being tested
- Stereotactic Hematoma Evacuation, MSCs Transplantation, Injectable Collagen Scaffold with MSCs Transplantation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Hematoma EvacuationProcedure or surgery
Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas, and then the drainage tube was pulled out.
MSCs TransplantationBiological
Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas,and 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out.
Injectable Collagen Scaffold with MSCs TransplantationBiological
Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas, and injectable collagen scaffold combined with 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Hematoma Evacuation | Sham comparator | Not described Receives: Procedure: Stereotactic Hematoma Evacuation |
| MSCs Transplantation | Experimental | Not described Receives: Biological: MSCs Transplantation |
| Injectable Collagen Scaffold with MSCs Transplantation | Experimental | Not described Receives: Biological: Injectable Collagen Scaffold with MSCs Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events and participants with those adverse events
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.
Measured: 24 month
Secondary outcomes (7)
Change in functional outcomes as measured by National Institutes of Health stroke scale (NIHSS) score
Measured: baseline, day 1-7, and 1, 3, 6, 12, 18 and 24 month after surgery
Change in motor recovery evaluated by Brunnstrom stage
Measured: 1, 3, 6, 12, 18 and 24 month after surgery
Change in self-care ability as measured by Barthel Index (BI)
Measured: 1, 3, 6, 12, 18 and 24 month after surgery
Change in pain intensity as measured by Visual Analogue Scale (VAS)
Measured: 1, 3, 6, 12, 18 and 24 month after surgery
Change in electrical brain activity as measured by Electroencephalography (EEG)
Measured: baseline, day 1, 4, 7, and 1, 3, 6, 12, 18, 24 month after surgery
Changes in brain electrophysiology as measured by Somatosensory evoked potential (SSEP)
Measured: baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery
Change in brain pathology diagnosed by Head CT scan
Measured: baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMar 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 Brain 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
- 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
- NCT02767817
- Sponsor's protocol ID
- CAS-XDA-BI/IGDB
- Status last verified
- Apr 2016
- First submitted
- 29 Apr 2016
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
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 Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Mesenchymal Stem Cells Transplantation in Patients With Brain Injury
- ClinicalTrials.gov ID
- NCT02767817
- Acronym / sponsor ID
- CAS-XDA-BI/IGDB
- Conditions
- Brain Injury
- Phase
- Phase 1
- 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
- Mar 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 May 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 safety and efficacy of injectable collagen scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Hematoma Evacuation | Sham comparator | Procedure: Stereotactic Hematoma Evacuation |
| MSCs Transplantation | Experimental | Biological: MSCs Transplantation |
| Injectable Collagen Scaffold with MSCs Transplantation | Experimental | Biological: Injectable Collagen Scaffold with MSCs Transplantation |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female，35-75 years old.
- The surgery time should be > 6 hours after symptom onset.
- Glasgow coma score (GCS) was 9-15.
- CT diagnosis of intracerebral hemorrhage (25-40 ml), except for patients with signs of craniotomy to remove the hematoma.
- Signed informed consent obtained from the patient or patient's legally authorized representative.
Key exclusion criteria (5 listed)
- Glasgow coma scale of <8.
- Patients suffering severe heart failure, severe lung disease, uremia, cirrhosis, end-stage cancer, coagulation disorders, stroke sequela.
- Asphyxia, cardiac arrest or successful cardiopulmonary resuscitation before hospitalization.
- Lactating or pregnant woman.
- Refuse to sign informed content.
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 |
|---|---|---|
| Stereotactic Hematoma EvacuationStereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas, and then the drainage tube was pulled out. | Procedure or surgery | Stereotactic Hematoma Evacuation |
| MSCs TransplantationStereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas,and 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out. | Biological | MSCs Transplantation |
| Injectable Collagen Scaffold with MSCs TransplantationStereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas, and injectable collagen scaffold combined with 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out. | Biological | Injectable Collagen Scaffold with MSCs Transplantation |
Primary outcome
Number of adverse events and participants with those adverse events
Time frame: 24 month
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.
7 secondary outcomes
Change in functional outcomes as measured by National Institutes of Health stroke scale (NIHSS) score
Time frame: baseline, day 1-7, and 1, 3, 6, 12, 18 and 24 month after surgery
Change in motor recovery evaluated by Brunnstrom stage
Time frame: 1, 3, 6, 12, 18 and 24 month after surgery
Change in self-care ability as measured by Barthel Index (BI)
Time frame: 1, 3, 6, 12, 18 and 24 month after surgery
Change in pain intensity as measured by Visual Analogue Scale (VAS)
Time frame: 1, 3, 6, 12, 18 and 24 month after surgery
Change in electrical brain activity as measured by Electroencephalography (EEG)
Time frame: baseline, day 1, 4, 7, and 1, 3, 6, 12, 18, 24 month after surgery
Changes in brain electrophysiology as measured by Somatosensory evoked potential (SSEP)
Time frame: baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery
Change in brain pathology diagnosed by Head CT scan
Time frame: baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery
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.
Related trials for Brain Injury
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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 study testing Stereotactic Hematoma Evacuation, MSCs Transplantation and Injectable Collagen Scaffold with MSCs Transplantation in people with Brain 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 5 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. Some participants in this study may receive a placebo. 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?
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?
Number of adverse events and participants with those adverse events (time frame: 24 month). 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.