Spinal Cord InjuriesPhase 2NCT03521323
Intrathecal Transplantation of UC-MSC in Patients With Early Stage of Chronic Spinal Cord Injury
A Phase 2 study testing Umbilical Cord Mesenchymal Stem Cells in people with Spinal Cord Injuries, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study aim to evaluate the safety and efficacy of intrathecal transplantation of allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different phrases of spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Umbilical Cord Mesenchymal Stem Cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2021
- Phase
- Phase 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
- Age 18 to 65
- Traumatic spinal cord injury
- ASIA Impairment Scale A-D
- Participants who understand and sign inform consent
- Duration of injury from 2 months to 12 months
Who cannot join
- Traumatic spinal cord injury with brain injury
- Non-traumatic spinal cord injury caused by spinal tumors, myelitis, demyelination, spinal vascular malformation, etc.
- with Ankylosing spondylitis
- with Malignant tumors
- with Neurodegenerative diseases, or any neuropathies
- with Hematologic diseases, or blood coagulation disorder
Show all 13Show fewer
- with Hepatic dysfunction, renal dysfunction
- Ongoing or active infectious diseases
- Pregnancy, or lactation women
- Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent
- Not agree to take part in clinical trial or can't finish follow up
- Previous history of MSCs therapy
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Limin Rong, M.D., 8620-85252900, ronglm@21cn.com
About this study
Official title: The Effect of Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells in Patients With Early Stage of Chronic Spinal Cord Injury：A Multicenter, Randomized, Controlled Trial
This study aim to evaluate the safety and efficacy of intrathecal transplantation of allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is 2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then find out the best time for SCI treatment.
In this part of the study, the investigators will treat patients with early stage of chronic spinal cord injury with UC-MSC transplantation or placebo.
Read the detailed description
Spinal cord injury (SCI), damage to any part of the spinal cord or nerves, often causes permanent neurofunction deficit, including strength, sensation and other body functions below the site of injury. WHO reported 15-40/million people suffer from SCI each year, about 250,000 to 500,000 people. The majority of SCI victims are young patients, who are at the time of working age. As a result of that, SCI not only affects the physical and psychological health of those patients, but also bring huge economic burden to their families, as well as the society. The current treatments for SCI mainly include surgical operation, neuroregenerative medicine, physical therapy, chinese acupuncture and so on. However, none of these methods are efficient enough to make any functional recovery of neurological injury in patients, and most patients will have to face paraplegia or tetraplegia.
The most challenge of SCI treatment are reported to be regeneration of axon and rewiring of the damaged spinal cord. The properties of strong proliferation and differentiation make stem cell transplantation possible to replace the damage axon and rebridge the injury spinal cord. Currently, evidences from animal experiments and pilot clinical studies have reported that umbilical cord mesenchymal stem cells transplantation was a potential method to treat spinal cord injury, but its safety and efficacy remain controversial.
This study will conduct a multicenter, randomized, controlled trial for UC-MSC transplantation for the treatment of different phrases of SCI, including sub-acute, early stage, and late stage of chronic SCI. These three trials will investigate the safety and efficacy of intrathecal transplantation of UC-MSC in patients with SCI treatment. The study will be conducted at 3 hospitals in China, covering eastern, southern and western of Chinese mainland.
The primary outcome is the changes of motor and sensory assessment before and after intervention using American Spinal Injury Association (ASIA) Score Scale. Secondary outcomes will include International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS), electromyogram test, residual urine test and adverse events.
The enrolled participants will be followed up at baseline, 1, 3, 6 and 12 months after UC-MSC transplantation. Besides, the samples of serum and cerebrospinal fluid will be collected, before and after treatment, to explore the potential mechanism of UC-MSC transplantation for the treatment of SCI.
The results of this study will, for the first time, provide high level of evidence as to the relative safety and efficacy of UC-MSC transplantation for the treatment of spinal cord injury.
- Conditions
- Spinal Cord Injuries
- Being tested
- Umbilical Cord Mesenchymal Stem Cells, Placebos
- Keywords
- umbilical cord mesenchymal stem cells, spinal cord injury
- 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.
Umbilical Cord Mesenchymal Stem CellsDrug
Also called UC-MSC
Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells
PlacebosDrug
Also called Sham operation
Placebos: Saline，Sham operation
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells | Experimental | Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells, 1*10^6 cells/kg, once a month for 4 months Receives: Drug: Umbilical Cord Mesenchymal Stem Cells |
| Control | Placebo comparator | Sham operation and 10ml saline as placebos, once a month for 4 months Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in American Spinal Injury Association (ASIA) Score Scale
Changes in motor and sensory scores assessed by the ASIA score scale (total score range from 0 to 324, higher values represent a better outcome)
Measured: Baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Secondary outcomes (3)
Changes in International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS)
Changes in motor and sensory scores assessed by IANR-SCIRFS scale (total score range from 0 to 51, higher values represent a better outcome)
Measured: Baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Changes in electromyogram test
Changes in electromyogram test
Measured: Baseline, 6 months and 12 months post-treatment
Changes in residual urine
Changes in residual urine measured by ultrasound test (volume of urine in mL, lower values represent a better outcome)
Measured: Baseline, 6 months and 12 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 posted11 May 2018
- Study start1 Sep 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 2:1 ratio of randomization (intervention group:control group) was used.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Shanghai East Hospital
- Responsible party
- Principal investigator, Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Limin Rong, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521323
- Sponsor's protocol ID
- IT-UCMSC-ECSCI
- Status last verified
- Apr 2019
- First submitted
- 12 Apr 2018
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Y, Pang M, Chen YY, Zhang LM, Liu H, Tan J, Liu B, Rong LM. Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial. Neural Regen Res. 2020 Aug;15(8):1532-1538. doi: 10.4103/1673-5374.274347.
PubMed 31997819
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells in Patients With Early Stage of Chronic Spinal Cord Injury：A Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03521323
- Acronym / sponsor ID
- IT-UCMSC-ECSCI
- Conditions
- Spinal Cord Injuries
- Keywords
- umbilical cord mesenchymal stem cells, spinal cord injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- West China Hospital, Shanghai East Hospital
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 May 2018 (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.
This study aim to evaluate the safety and efficacy of intrathecal transplantation of allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is 2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then find out the best time for SCI treatment.
In this part of the study, the investigators will treat patients with early stage of chronic spinal cord injury with UC-MSC transplantation or placebo.
Detailed description
Spinal cord injury (SCI), damage to any part of the spinal cord or nerves, often causes permanent neurofunction deficit, including strength, sensation and other body functions below the site of injury. WHO reported 15-40/million people suffer from SCI each year, about 250,000 to 500,000 people. The majority of SCI victims are young patients, who are at the time of working age. As a result of that, SCI not only affects the physical and psychological health of those patients, but also bring huge economic burden to their families, as well as the society. The current treatments for SCI mainly include surgical operation, neuroregenerative medicine, physical therapy, chinese acupuncture and so on. However, none of these methods are efficient enough to make any functional recovery of neurological injury in patients, and most patients will have to face paraplegia or tetraplegia.
The most challenge of SCI treatment are reported to be regeneration of axon and rewiring of the damaged spinal cord. The properties of strong proliferation and differentiation make stem cell transplantation possible to replace the damage axon and rebridge the injury spinal cord. Currently, evidences from animal experiments and pilot clinical studies have reported that umbilical cord mesenchymal stem cells transplantation was a potential method to treat spinal cord injury, but its safety and efficacy remain controversial.
This study will conduct a multicenter, randomized, controlled trial for UC-MSC transplantation for the treatment of different phrases of SCI, including sub-acute, early stage, and late stage of chronic SCI. These three trials will investigate the safety and efficacy of intrathecal transplantation of UC-MSC in patients with SCI treatment. The study will be conducted at 3 hospitals in China, covering eastern, southern and western of Chinese mainland.
The primary outcome is the changes of motor and sensory assessment before and after intervention using American Spinal Injury Association (ASIA) Score Scale. Secondary outcomes will include International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS), electromyogram test, residual urine test and adverse events.
The enrolled participants will be followed up at baseline, 1, 3, 6 and 12 months after UC-MSC transplantation. Besides, the samples of serum and cerebrospinal fluid will be collected, before and after treatment, to explore the potential mechanism of UC-MSC transplantation for the treatment of SCI.
The results of this study will, for the first time, provide high level of evidence as to the relative safety and efficacy of UC-MSC transplantation for the treatment of spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A 2:1 ratio of randomization (intervention group:control group) was used.
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells | Experimental | Drug: Umbilical Cord Mesenchymal Stem CellsIntrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells, 1*10^6 cells/kg, once a month for 4 months |
| Control | Placebo comparator | Drug: PlacebosSham operation and 10ml saline as placebos, once a month for 4 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65
- Traumatic spinal cord injury
- ASIA Impairment Scale A-D
- Participants who understand and sign inform consent
- Duration of injury from 2 months to 12 months
Key exclusion criteria (13 listed)
- Traumatic spinal cord injury with brain injury
- Non-traumatic spinal cord injury caused by spinal tumors, myelitis, demyelination, spinal vascular malformation, etc.
- with Ankylosing spondylitis
- with Malignant tumors
- with Neurodegenerative diseases, or any neuropathies
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 |
|---|---|---|
| Umbilical Cord Mesenchymal Stem CellsAlso: UC-MSCIntrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells | Drug | Umbilical Cord Mesenchymal Stem Cells |
| PlacebosAlso: Sham operationPlacebos: Saline，Sham operation | Drug | Control |
Primary outcome
Changes in American Spinal Injury Association (ASIA) Score Scale
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Changes in motor and sensory scores assessed by the ASIA score scale (total score range from 0 to 324, higher values represent a better outcome)
3 secondary outcomes
Changes in International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS)
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Changes in electromyogram test
Time frame: Baseline, 6 months and 12 months post-treatment
Changes in residual urine
Time frame: Baseline, 6 months and 12 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 May 2019.
- Derived from this study: PubMed 31997819Yang Y, Pang M, Chen YY, Zhang LM, Liu H, Tan J, Liu B, Rong LM. Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial. Neural Regen Res. 2020 Aug;15(8):1532-1538. doi: 10.4103/1673-5374.274347.
- Individual participant dataSharing planned: No
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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.
Limin Rong, M.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Umbilical Cord Mesenchymal Stem Cells in people with Spinal Cord Injuries, run by Third Affiliated Hospital, Sun Yat-Sen University 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 1 May 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. 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 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 Limin Rong, M.D. (862085252900, ronglm@21cn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in American Spinal Injury Association (ASIA) Score Scale (time frame: Baseline, 1 month, 3 months, 6 months and 12 months post-treatment). 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 NCT03521323, which also lists 1 linked publication.
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 May 2019.