Spinal Cord InjuriesPhase 2NCT01393977
Difference Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With Spinal Cord Injury in China
A Phase 2 study testing rehabilitation of limb function and Stem Cells Transplantation in people with Spinal Cord Injuries, 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 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, its effect to improve the neurological disorders of these patients, such as… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- rehabilitation of limb function and Stem Cells Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to May 2012
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients or their curator must be able to give voluntary consent.
- Patients or their curator Must be able to understand the information of study and in which group they are.
- 20 years - 50 years of age can be enrolled.
- Both male and female can be enrolled.
- Patients have clear history of traumatic injury, and the spinal cord injury are confirmed by all of the examinations including MRI, electromyogram and electrophysiology.
Who cannot join
- Mental disorders
- Myelitis
- Women in pregnancy
- Cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yihua An
Beijing
Yihua An, doctor, 0086-10-88276848, doctoran2010@hotmail.com
About this study
Official title: Efficacy Difference Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Acute or Chronic Spinal Cord Injury in China
The morbidity of spinal cord injury (SCI) is increasing 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, its effect to improve the neurological disorders of these patients, such as the dysfunction of sense, motor, autologous adjustment of blood pressure control of urination and defecation, perspiration , etc. is unsatisfying. 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, the investigators use mesenchymal stem cells derived from umbilical cord to treat 40 SCI patients (20 cases in early stage and 20 cases in sequela stage). The investigators also follow-up ten patients who only receive rehabilitation and another ten outpatients 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 Injuries
- Being tested
- rehabilitation of limb function, Stem Cells Transplantation
- Keywords
- Spinal Cord Injuries, Stem 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.
rehabilitation of limb functionProcedure or surgery
Also called phsical exercise rehabilitation
only receive rehabilitation of limb function
Stem Cells TransplantationProcedure or surgery
mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Outpatient in hospital |
| rehabilitation | Active comparator | interventions: rehabilitation Receives: Procedure: rehabilitation of limb function |
| Stem Cell Transplantation | Experimental | interventions: stem cell transplantation Receives: Procedure: Stem Cells Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyogram and Electroneurophysiologic test
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
Measured: 3 monthes after enrollment or transplantation
Secondary outcomes (2)
Electromyogram and Electroneurophysiologic test
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
Measured: 6monthes after enrollment or transplantation
Electromyogram and Electroneurophysiologic test
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
Measured: 12monthes after enrollment or transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011 (estimated)
- Study completionMay 2012 (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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Chinese Armed Police Forces
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- An Yihua, doctor, Study director, Chinese People's Armed Police Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393977
- Sponsor's protocol ID
- 2011-01-19SCI
- Status last verified
- Oct 2011
- First submitted
- 6 Jul 2011
- Last updated
- 10 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheng H, Liu X, Hua R, Dai G, Wang X, Gao J, An Y. Clinical observation of umbilical cord mesenchymal stem cell transplantation in treatment for sequelae of thoracolumbar spinal cord injury. J Transl Med. 2014 Sep 12;12:253. doi: 10.1186/s12967-014-0253-7.
PubMed 25209445
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Difference Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Acute or Chronic Spinal Cord Injury in China
- ClinicalTrials.gov ID
- NCT01393977
- Acronym / sponsor ID
- 2011-01-19SCI
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Stem Cell Transplantation, Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 14 Jul 2011 (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 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, its effect to improve the neurological disorders of these patients, such as the dysfunction of sense, motor, autologous adjustment of blood pressure control of urination and defecation, perspiration , etc. is unsatisfying. 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, the investigators use mesenchymal stem cells derived from umbilical cord to treat 40 SCI patients (20 cases in early stage and 20 cases in sequela stage). The investigators also follow-up ten patients who only receive rehabilitation and another ten outpatients 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Outpatient in hospital |
| rehabilitation | Active comparator | Procedure: rehabilitation of limb functioninterventions: rehabilitation |
| Stem Cell Transplantation | Experimental | Procedure: Stem Cells Transplantationinterventions: stem cell transplantation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients or their curator must be able to give voluntary consent.
- Patients or their curator Must be able to understand the information of study and in which group they are.
- 20 years - 50 years of age can be enrolled.
- Both male and female can be enrolled.
- Patients have clear history of traumatic injury, and the 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 |
|---|---|---|
| rehabilitation of limb functionAlso: phsical exercise rehabilitationonly receive rehabilitation of limb function | Procedure or surgery | rehabilitation |
| Stem Cells Transplantationmesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture | Procedure or surgery | Stem Cell Transplantation |
Primary outcome
Electromyogram and Electroneurophysiologic test
Time frame: 3 monthes after enrollment or transplantation
Brain stem auditory evoked potential (BAEP)and electromyography can display the nerve conduction velocity and the improvement of neurological function.
2 secondary outcomes
Electromyogram and Electroneurophysiologic test
Time frame: 6monthes after enrollment or transplantation
Electromyogram and Electroneurophysiologic test
Time frame: 12monthes after enrollment or transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2011.
- Derived from this study: PubMed 25209445Cheng H, Liu X, Hua R, Dai G, Wang X, Gao J, An Y. Clinical observation of umbilical cord mesenchymal stem cell transplantation in treatment for sequelae of thoracolumbar spinal cord injury. J Transl Med. 2014 Sep 12;12:253. doi: 10.1186/s12967-014-0253-7.
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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.
An Yihua, doctor study director
Chinese People's Armed Police Force
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 rehabilitation of limb function and Stem Cells Transplantation in people with Spinal Cord Injuries, 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 5 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: status not confirmed, as of the sponsor's last update on 10 Oct 2011. 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyogram and Electroneurophysiologic test (time frame: 3 monthes after enrollment or transplantation). 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 NCT01393977, 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 10 Oct 2011.