Spinal Cord InjuriesPhase 1/2NCT02481440
Repeated Subarachnoid Administrations of hUC-MSCs in Treating SCI
A Phase 1/2 study testing human umbilical cord mesenchymal stem cells (hUC-MSCs) in people with Spinal Cord Injuries, run by Limin Rong at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of repeated intrathecal administrations of allogeneic human umbilical cord mesenchymal stem cells for the treatment 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?
- human umbilical cord mesenchymal stem cells (hUC-MSCs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2018to 31 Mar 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- complete or incomplete trauma-induced SCI [American Spinal Injury Association (ASIA) Impairment Scale classification: A-D] that happened at least two months before recruitment;
- aged between 18 and 65 years;
- agreed to participate in this study voluntarily and be regularly followed up for 12 months after the completion of hUC-MSCs administration
Who cannot join
- ankylosing spondylitis, myelitis, or vascular abnormalities within the spinal cord parenchyma;
- severe comorbidities, including but not limited to craniocerebral injury, cutaneous back infection, psychiatric disease, or cancer;
- pregnancy or lactation (for females);
- predicted lifespan of less than 12 months following the end of hUC-MSCs transplantation;
- participation in any other stem cell-related clinical trials that might affect accurate neurological evaluations in the present trial;
- any medical condition that, in the opinion of investigators, may pose a safety risk to any subject in this study, confound safety or efficacy assessments, or interfere with study participation
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- Rejection Criteria:
- misdiagnosis;
- use of any medication that may significantly impact the assessment accuracy of stem cell engraftment;
- absence of any evaluation outcome at any time point during the follow-up period
- Cessation Criteria:
- individual wishes of the subjects;
- occurrence of any stem cell-associated serious adverse event (SAE) that may aggravate neurological dysfunction, or require prolongation of existing hospitalization, or need hospital readmission, or impair consciousness, or be life-threatening, or even lead to death in any subject;
- detection of any major mistake in the present protocol during the implementation of this clinical trial;
- the national administration agency requires the clinical trial to be halted
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: Repeated Subarachnoid Administrations of Human Umbilical Cord Mesenchymal Stem Cells in Treating Spinal Cord Injury
The purpose of this study is to evaluate the safety and efficacy of repeated intrathecal administrations of allogeneic human umbilical cord mesenchymal stem cells for the treatment of spinal cord injury.
Read the detailed description
Spinal cord injury (SCI) is a devastating disease and often leads to lifelong disability, muscle spasm, sensory deficits, autonomic disturbances, as well as bowel and bladder incontinence, all of which can cause tremendous troubles to patients but are lack of any effective treatment up to now. SCI is not only a severe healthy problem but also a great social burden. To the best of our knowledge, cell therapy seems to be a promising alternative for the treatment of SCI due to numerous advantages. However, cytotherapy is still in its infancy since there are many disparities and uncertainties regarding subject selection, cellular type, transplantation timing, administration dose and deliver route in clinical trial protocols. Hence, a standardized well-designed clinical study is urgently required for the safe and effective treatment of SCI.
In this study, complete or incomplete cervical, thoracic, and thoracolumbar SCI subjects were recruited to join in a prospective, single-center, single-arm clinical trial. Intervention is four times of subarachnoid administration of allogeneic hUC-MSCs. During the intervention and follow-up periods of this trial, any adverse event was identified rapidly and managed properly. The maximum intensity and relationship of any adverse event with hUC-MSCs administration were identified.The primary efficacy indicator is American spinal injury association (ASIA) total score at the fourth follow-up and SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) total score at the fourth follow-up. Secondary efficacy indicators are these two indicators at the remaining time points, scores of pin prick, light touch, motor and sphincter, muscle spasticity and spasm, autonomic system, bladder and bowel functions, residual urine volume. Subgroup analysis of primary efficacy indicators was also performed.
In this trial, informed consent forms that had the approval of the institutional review board were obtained from all participants before recruitment. In this clinical study, subarachnoid transplantation of hUC-MSCs was performed a total of four times per subject with the delivery dose of 1×10E6 cells/kg. After the completion of cytotherapy, subject was regularly followed up in the hospital at four time points, determined at 1, 3, 6, and 12 months following the final administration of hUC-MSCs. At each time point of administration (the first, second, third, and fourth transplantation) and follow-up (the first, second, third, and fourth follow-up), safety and efficacy indicators were collected accordingly by two independent assessors.
- Conditions
- Spinal Cord Injuries
- Being tested
- human umbilical cord mesenchymal stem cells (hUC-MSCs)
- Keywords
- human 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.
human umbilical cord mesenchymal stem cells (hUC-MSCs)Biological
Also called umbilical cord mesenchymal stem cells
Four times of intrathecal administrations of hUC-MSCs
| Study group | Role | What they receive |
|---|---|---|
| hUC-MSC Transplantation | Experimental | Repeated intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration Receives: Biological: human umbilical cord mesenchymal stem cells (hUC-MSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Spinal Injury Association (ASIA) Total Score at the Fourth Follow-up
American Spinal Injury Association (ASIA) form is used to assess ASIA total score (Range: 0-324 scores). The higher scores mean a better outcome.
Measured: at 12 months following the final administration of hUC-MSCs
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score at the Fourth Follow-up
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) form is used to assess IANR-SCIFRS total score (Range: 0-51 scores). The higher scores mean a better outcome.
Measured: at 12 months following the final administration of hUC-MSCs
Secondary outcomes (8)
American Spinal Injury Association (ASIA) Total Score
American Spinal Injury Association (ASIA) form is used to assess ASIA total score (Range: 0-324 scores). The higher scores mean a better outcome.
Measured: at first, second, third, and fourth transplantation and 1, 3, 6 months following the final administration of hUC-MSCs
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) form is used to assess IANR-SCIFRS total score (Range: 0-51 scores). The higher scores mean a better outcome.
Measured: at first, second, third, and fourth transplantation and 1, 3, 6 months following the final administration of hUC-MSCs
International Standards to Document Remaining Autonomic Function After Spinal Cord Injury (ISAFSCI) Score
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) form is used to assess ISAFSCI score (autonomic nervous function) (Range: 5-32 scores). The higher scores mean a better outcome.
Measured: at first transplantation and 12 months following the final administration of hUC-MSCs
Penn Scale
Penn scale form is used to assess muscle spasm (Range: 0-4 scores). The higher scores mean a worse outcome.
Measured: at first transplantation and 12 months following the final administration of hUC-MSCs
Modified Ashworth Scale
Modified Ashworth scale form is used to assess muscle spasticity (Range: 0-16 scores). The higher scores mean a worse outcome.
Measured: at first transplantation and 1, 3, 12 months following the final administration of hUC-MSCs
Geffner Scale
Geffner scale form is used to assess bladder function (Range: 0-7 scores). The higher scores mean a better outcome.
Measured: at first transplantation and 12 months following the final administration of hUC-MSCs
Neurogenic Bowel Dysfunction (NBD) Scale
Neurogenic Bowel Dysfunction (NBD) scale form is used to assess bowel function (Range: 0-47 scores). The higher scores mean a worse outcome.
Measured: at first transplantation and 12 months following the final administration of hUC-MSCs
Residual Urine Volume
Ultrasonic examination is used to assess residual urine volume
Measured: at first transplantation and 12 months following the final administration of hUC-MSCs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start30 Mar 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limin Rong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Min Li Rong, M.D., Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481440
- Sponsor's protocol ID
- hUC-MSC-SCI
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2015
- Last updated
- 30 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Subarachnoid Administrations of Human Umbilical Cord Mesenchymal Stem Cells in Treating Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02481440
- Acronym / sponsor ID
- hUC-MSC-SCI
- Conditions
- Spinal Cord Injuries
- Keywords
- human umbilical cord mesenchymal stem cells, spinal cord injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Limin RongUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 30 Jun 2020
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 evaluate the safety and efficacy of repeated intrathecal administrations of allogeneic human umbilical cord mesenchymal stem cells for the treatment of spinal cord injury.
Detailed description
Spinal cord injury (SCI) is a devastating disease and often leads to lifelong disability, muscle spasm, sensory deficits, autonomic disturbances, as well as bowel and bladder incontinence, all of which can cause tremendous troubles to patients but are lack of any effective treatment up to now. SCI is not only a severe healthy problem but also a great social burden. To the best of our knowledge, cell therapy seems to be a promising alternative for the treatment of SCI due to numerous advantages. However, cytotherapy is still in its infancy since there are many disparities and uncertainties regarding subject selection, cellular type, transplantation timing, administration dose and deliver route in clinical trial protocols. Hence, a standardized well-designed clinical study is urgently required for the safe and effective treatment of SCI.
In this study, complete or incomplete cervical, thoracic, and thoracolumbar SCI subjects were recruited to join in a prospective, single-center, single-arm clinical trial. Intervention is four times of subarachnoid administration of allogeneic hUC-MSCs. During the intervention and follow-up periods of this trial, any adverse event was identified rapidly and managed properly. The maximum intensity and relationship of any adverse event with hUC-MSCs administration were identified.The primary efficacy indicator is American spinal injury association (ASIA) total score at the fourth follow-up and SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) total score at the fourth follow-up. Secondary efficacy indicators are these two indicators at the remaining time points, scores of pin prick, light touch, motor and sphincter, muscle spasticity and spasm, autonomic system, bladder and bowel functions, residual urine volume. Subgroup analysis of primary efficacy indicators was also performed.
In this trial, informed consent forms that had the approval of the institutional review board were obtained from all participants before recruitment. In this clinical study, subarachnoid transplantation of hUC-MSCs was performed a total of four times per subject with the delivery dose of 1×10E6 cells/kg. After the completion of cytotherapy, subject was regularly followed up in the hospital at four time points, determined at 1, 3, 6, and 12 months following the final administration of hUC-MSCs. At each time point of administration (the first, second, third, and fourth transplantation) and follow-up (the first, second, third, and fourth follow-up), safety and efficacy indicators were collected accordingly by two independent assessors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hUC-MSC Transplantation | Experimental | Biological: human umbilical cord mesenchymal stem cells (hUC-MSCs)Repeated intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- complete or incomplete trauma-induced SCI [American Spinal Injury Association (ASIA) Impairment Scale classification: A-D] that happened at least two months before recruitment;
- aged between 18 and 65 years;
- agreed to participate in this study voluntarily and be regularly followed up for 12 months after the completion of hUC-MSCs administration
Key exclusion criteria (15 listed)
- ankylosing spondylitis, myelitis, or vascular abnormalities within the spinal cord parenchyma;
- severe comorbidities, including but not limited to craniocerebral injury, cutaneous back infection, psychiatric disease, or cancer;
- pregnancy or lactation (for females);
- predicted lifespan of less than 12 months following the end of hUC-MSCs transplantation;
- participation in any other stem cell-related clinical trials that might affect accurate neurological evaluations in the present trial;
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 |
|---|---|---|
| human umbilical cord mesenchymal stem cells (hUC-MSCs)Also: umbilical cord mesenchymal stem cellsFour times of intrathecal administrations of hUC-MSCs | Biological | hUC-MSC Transplantation |
Primary outcome
American Spinal Injury Association (ASIA) Total Score at the Fourth Follow-up
Time frame: at 12 months following the final administration of hUC-MSCs
American Spinal Injury Association (ASIA) form is used to assess ASIA total score (Range: 0-324 scores). The higher scores mean a better outcome.
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score at the Fourth Follow-up
Time frame: at 12 months following the final administration of hUC-MSCs
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) form is used to assess IANR-SCIFRS total score (Range: 0-51 scores). The higher scores mean a better outcome.
8 secondary outcomes
American Spinal Injury Association (ASIA) Total Score
Time frame: at first, second, third, and fourth transplantation and 1, 3, 6 months following the final administration of hUC-MSCs
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score
Time frame: at first, second, third, and fourth transplantation and 1, 3, 6 months following the final administration of hUC-MSCs
International Standards to Document Remaining Autonomic Function After Spinal Cord Injury (ISAFSCI) Score
Time frame: at first transplantation and 12 months following the final administration of hUC-MSCs
Penn Scale
Time frame: at first transplantation and 12 months following the final administration of hUC-MSCs
Modified Ashworth Scale
Time frame: at first transplantation and 1, 3, 12 months following the final administration of hUC-MSCs
Geffner Scale
Time frame: at first transplantation and 12 months following the final administration of hUC-MSCs
Neurogenic Bowel Dysfunction (NBD) Scale
Time frame: at first transplantation and 12 months following the final administration of hUC-MSCs
Residual Urine Volume
Time frame: at first transplantation and 12 months following the final administration of hUC-MSCs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Min Li Rong, M.D. principal investigator
Third Affiliated Hospital, 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 1/2 study testing human umbilical cord mesenchymal stem cells (hUC-MSCs) in people with Spinal Cord Injuries, run by Limin Rong 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 3 inclusion and 15 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: finished, as of the sponsor's last update on 30 Jun 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?
Yes. Results are posted in the registry (first posted 30 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
American Spinal Injury Association (ASIA) Total Score at the Fourth Follow-up (time frame: at 12 months following the final administration of hUC-MSCs). 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 30 Jun 2020; AzTrials last refreshed its copy on 2 Nov 2026.