Spinal Cord InjuryPhase 3SCI-IIINCT01873547
Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China
A Phase 3 study testing cell therapy and rehabilitation in people with Spinal Cord Injury, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
Trial summary
The morbidity of spinal cord injury (SCI) is increasing year by year significantly in China. The methods to treat SCI patients in sequela stage update are poor. Though traditional rehabilitation therapy is the routine method to treat SCI in sequela stage, aiming to improve the neurological disorders of these patients… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- cell therapy and rehabilitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2015
- Phase
- Phase 3
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients or their curator must be able to give voluntary consent.
- Patients have clear history of traumatic injury.
- 20 years - 65 years of age can be enrolled.
- Both male and female can be enrolled.
- The diagnosis of spinal cord injury are confirmed by all of the examinations including MRI, electromyogram and electrophysiology.
- The time of injury was longer than 1 year.
Who cannot join
- Mental disorders
- Myelitis
- Women in pregnancy
- Cancer
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Chinese People's Armed Police Forces
Beijing, Beijing Municipality, 100050
About this study
Official title: Different Efficacy Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Chronic Spinal Cord Injury in China
The morbidity of spinal cord injury (SCI) is increasing year by year significantly in China. The methods to treat SCI patients in sequela stage update are poor. Though traditional rehabilitation therapy is the routine method to treat SCI in sequela stage, aiming to improve the neurological disorders of these patients, such as sensory disturbance, dyskinesia, autologous adjustment of blood pressure, dysfunction of urination, defecation and perspiration , etc. What's a pity, the efficacy of the rehabilitation therapy is unsatisfactory. Rehabilitation Therapy can prevent the process of muscle atrophy and joint stiffness. However, it can not repair the damaged nerve function. Studies show that mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI in animals without any severe side effect.
In this study, 300 patients will be divided into three groups and the investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 SCI patients. They will also follow up 100 patients who only receive rehabilitation and another 100 patients who accept neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare the efficacy of these two treatments.
Read the detailed description
Patients enrolled in this study need to finish our whole follow-up survey, which is carried out by clinical doctors and epidemiologist.
- Conditions
- Spinal Cord Injury
- Being tested
- cell therapy, rehabilitation
- Keywords
- spinal cord injury, cell transplantation, rehabilitation
- 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.
cell therapyBiological
Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.
rehabilitationOther
Also called physical exercise rehabilitation
Patients only receive rehabilitation of limb function.
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation | Active comparator | Patients in the group accept rehabilitation for three weeks in hospital and other eleven months in their home under the guidance of physical therapist. Receives: Other: rehabilitation |
| cell therapy | Experimental | Patients in the group accept cell therapy including four times stem cells transplant via intrathecal injection. Receives: Biological: cell therapy |
| control | No intervention | Patients receive no professional treatment in hospital or rehabilitation centre. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in International Standards for Neurological Classification of Spinal Cord Injury according to American Spine Injury Association
ASIA is American Spine Injury Association.The ASIA publishes the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), which is a neurological exam widely used to document sensory and motor impairments following spinal cord injury (SCI). The ASIA assessment is the gold standard for assessing SCI. The exam is based on neurological responses, touch and pinprick sensations tested in each dermatome, and strength of the muscles that control key motions on both sides of the body. Muscle strength is scored on a scale of 0-5 according to the adjacent table, and sensation is graded on a scale of 0-2: 0 is no sensation, 1 is altered or decreased sensation, and 2 is full sensation. Each side of the body is graded independently. The ISNCSCI exam is used for determining the neurological level of injury. ASIA Impairment Scale for classifying spinal cord injury includes five grades: A, B, C, D and E.
Measured: Baseline, 6 and 12 months after recruitment
Secondary outcomes (3)
Assessment of changes in score of pain index using Short-form McGill Pain Questionnaire
The McGill Pain Questionnaire (MPQ) is an international standard scale for description and evaluation of pain.The Short-form McGill Pain Questionnaire (SF-MPQ) is simplified on the basis of MPQ and has high reliability in clinical applications.The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
Measured: Baseline,6 and 12 months after recruitment
Assessment of changes in score of activity of daily living
Bathal Index (BI) is one of the most commonly used methods for measuring the activity of daily living. The BI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of spinal cord injury: (1)Fatigue; (2)Spinal pain; (3)Arthralgia (joint pain) or swelling; (4)Enthesitis, or inflammation of tendons and ligaments (areas of localized tenderness where connective tissues insert into bone); (5)Morning stiffness duration; (6)Morning stiffness severity.
Measured: Baseline, 6 and 12 months after recruitment
Assessment of changes in sensory evoked potentials and motor evoked potentials
A bipolar electrode was placed at 2-3 cm near the distal end of the wrist wrinkle to stimulate the median nerve. An anode was placed near the proximal end. Electrodes for recording were placed at the ipsilateral supraclavicular fossa (Erb') and 1-2 cm above the spinous process of C7 and C4' (for recording of somatosensory evoked potential on the left median nerve) or C3' (for recording of somatosensory evoked potential on the right median nerve). Recordings were made separately on the left and right sides. 200 potentials on each body side were recorded and superimposed. Results of recordings will show whether the latency is apposite or similar with normal.
Measured: Baseline,6 and 12 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJun 2012
- Primary completionOct 2014
- Study completionDec 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cell therapy or rehabitation treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Chinese Armed Police Forces
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yihua An, Ph.D, Study director, the General Hospital of Chinese People's Armed Police Forces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873547
- Sponsor's protocol ID
- 2013-03-04SCI-III
- Acronym
- SCI-III
- Status last verified
- May 2018
- First submitted
- 4 Jun 2013
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Efficacy Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Chronic Spinal Cord Injury in China
- ClinicalTrials.gov ID
- NCT01873547
- Acronym / sponsor ID
- SCI-III / 2013-03-04SCI-III
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, cell transplantation, rehabilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jun 2013 (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 morbidity of spinal cord injury (SCI) is increasing year by year significantly in China. The methods to treat SCI patients in sequela stage update are poor. Though traditional rehabilitation therapy is the routine method to treat SCI in sequela stage, aiming to improve the neurological disorders of these patients, such as sensory disturbance, dyskinesia, autologous adjustment of blood pressure, dysfunction of urination, defecation and perspiration , etc. What's a pity, the efficacy of the rehabilitation therapy is unsatisfactory. Rehabilitation Therapy can prevent the process of muscle atrophy and joint stiffness. However, it can not repair the damaged nerve function. Studies show that mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI in animals without any severe side effect.
In this study, 300 patients will be divided into three groups and the investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 SCI patients. They will also follow up 100 patients who only receive rehabilitation and another 100 patients who accept neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare the efficacy of these two treatments.
Detailed description
Patients enrolled in this study need to finish our whole follow-up survey, which is carried out by clinical doctors and epidemiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- cell therapy or rehabitation treatment
| Arm | Type | Receives |
|---|---|---|
| rehabilitation | Active comparator | Other: rehabilitationPatients in the group accept rehabilitation for three weeks in hospital and other eleven months in their home under the guidance of physical therapist. |
| cell therapy | Experimental | Biological: cell therapyPatients in the group accept cell therapy including four times stem cells transplant via intrathecal injection. |
| control | No intervention | –Patients receive no professional treatment in hospital or rehabilitation centre. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients or their curator must be able to give voluntary consent.
- Patients have clear history of traumatic injury.
- 20 years - 65 years of age can be enrolled.
- Both male and female can be enrolled.
- The diagnosis of spinal cord injury are confirmed by all of the examinations including MRI, electromyogram and electrophysiology.
Key exclusion criteria (4 listed)
- Mental disorders
- Myelitis
- Women in pregnancy
- Cancer
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 |
|---|---|---|
| cell therapyMesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture. | Biological | cell therapy |
| rehabilitationAlso: physical exercise rehabilitationPatients only receive rehabilitation of limb function. | Other | rehabilitation |
Primary outcome
Assessment of changes in International Standards for Neurological Classification of Spinal Cord Injury according to American Spine Injury Association
Time frame: Baseline, 6 and 12 months after recruitment
ASIA is American Spine Injury Association.The ASIA publishes the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), which is a neurological exam widely used to document sensory and motor impairments following spinal cord injury (SCI). The ASIA assessment is the gold standard for assessing SCI. The exam is based on neurological responses, touch and pinprick sensations tested in each dermatome, and strength of the muscles that control key motions on both sides of the body. Muscle strength is scored on a scale of 0-5 according to the adjacent table, and sensation is graded on a scale of 0-2: 0 is no sensation, 1 is altered or decreased sensation, and 2 is full sensation. Each side of the body is graded independently. The ISNCSCI exam is used for determining the neurological level of injury. ASIA Impairment Scale for classifying spinal cord injury includes five grades: A, B, C, D and E.
3 secondary outcomes
Assessment of changes in score of pain index using Short-form McGill Pain Questionnaire
Time frame: Baseline,6 and 12 months after recruitment
Assessment of changes in score of activity of daily living
Time frame: Baseline, 6 and 12 months after recruitment
Assessment of changes in sensory evoked potentials and motor evoked potentials
Time frame: Baseline,6 and 12 months after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
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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.
Yihua An, Ph.D study director
the General Hospital of Chinese People's Armed Police Forces
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cell therapy and rehabilitation in people with Spinal Cord Injury, run by General Hospital of Chinese Armed Police Forces 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 6 inclusion and 4 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 25 May 2018. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of changes in International Standards for Neurological Classification of Spinal Cord Injury according to American Spine Injury Association (time frame: Baseline, 6 and 12 months after recruitment). 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 25 May 2018.