Spinal Cord InjuryPhase 2NCT02574585
Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury
A Phase 2 study testing Autologous mesenchymal cells transplantation in people with Spinal Cord Injury, run by Hospital Sao Rafael.
Trial summary
The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Autologous mesenchymal cells transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Jan 2022
- 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
- Blunt spinal cord injury at thoracolumbar level, between T1 and L2, or penetrating spinal cord injury, at the same level, provided that the mechanism of injury had been spinal shock, ischemia or hematoma, with at least 12 months of injury;
- ASIA grade A;
- Signing of the written consent.
Who cannot join
- Spinal cord injuries by sharp objects, firearms, and not traumatic or congenital causes, even if at different levels of the spinal cord;
- Concomitant brain injuries;
- Diabetes mellitus type 1 or 2 as defined by fasting glucose above 126 mg / use of medication and medical history;
- Infectious processes in acute and / or chronic course, confirmed by additional tests and / or medical history;
- Immunodeficiency, autoimmune diseases and neoplastic processes, confirmed by additional tests and / or medical history;
- Terminal, neurodegenerative, primary hematologic and musculoskeletal diseases confirmed by additional tests and / or past medical history;
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- Osteopathies reflecting increased risk for bone marrow puncture;
- Coagulopathies;
- Severe organ failure (heart, kidney or liver), confirmed by additional tests or medical history;
- Pregnancy or lactation;
- Clinical complications that hinder or contraindicate the surgical procedure;
- Use of metallic implants near vascular structures (such as cardiac pacemaker), or other contraindication to magnetic resonance imaging;
- Psychiatric disorders, psychosocial and cognitive impairment confirmed by medical evaluation;
- Abusive use of alcohol and / or illegal substances use;
- Participation in other clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Clinical Trial for the Evaluation of Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury
The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete spinal cord injury.
Read the detailed description
This is a randomized, non-placebo controlled, prospective, phase II clinical trial. The study population will consist of 40 patients who had spinal cord injury for at least 12 months, with thoracolumbar chronic and complete spinal cord injury, ASIA grade A.
A practitioner, a surgeon and a nurse will review the medical records of the patients to determine the presence / absence of inclusion / exclusion criteria. If the patient is a potential candidate for the study, an interview will be scheduled to review and confirm his/her eligibility. Patients will undergo a series of clinical and neurological assessments and will also be submitted to the following procedures:
- Cell blood count;
- Biochemical analysis (measurement of electrolytes - sodium, potassium, magnesium);
- Renal function tests (urea and creatinine);
- Liver function tests;
- Coagulation profile;
- Metabolic profile (glucose, total cholesterol and fractions);
- Urine summary and culture;
- Serology required for blood transfusion and marrow transplant in Brazil;
- Electrocardiogram;
- Chest X-Ray;
- Bone densitometry;
- Urodynamic studies;
- Somatosensory evoked potential;
- Computed tomography of thoracic and lumbar spine;
- Magnetic resonance imaging of the thoracic and lumbar spine.
Also as part of the preoperative evaluation, the patients will respond to questions from the SF (Short Form) -36 questionnaire (for assessment of quality of life) and the questionnaires for the assessment of neuropathic pain. Clinical follow-up will be kept for patients who suspend their participation in the study for any adverse event and / or laboratory abnormality, or for the patient's own desire, following insurance protocols. In addition to the clinical and surgical follow-up, specific medical care will be offered to patients who experience adverse events, until stabilization of the patient, even if the target date for completion of the study has been exceeded. The candidates included in the study will be asked to voluntarily participate and give their informed written consent.
- Conditions
- Spinal Cord Injury
- Being tested
- Autologous mesenchymal cells transplantation
- Keywords
- Spinal cord injury, Paraplegia, Stem cells, Mesenchymal cells
- Medical subject headings
- Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal cells transplantationBiological
Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Experimental | Twenty subjects will be randomly assigned to receive two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections. Receives: Biological: Autologous mesenchymal cells transplantation |
| Control group | No intervention | Twenty subjects will be randomly assigned to be clinically followed, without any specific intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury
Measured: 12 months
Secondary outcomes (3)
Functional improvement in ASIA (American Spinal Injury Association) grade
The investigators will evaluate the conversion rate from ASIA A to B or C in 12 months.
Measured: 12 months
Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force)
AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor force in 12 months.
Measured: 12 months
Improvements in sensorial mapping and neuropathic pain
The patients will be submitted to specific questionnaires and clinical examinations in order to evaluate improvements in sensorial mapping and neuropathic pain.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startDec 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Rafael
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Ribeiro dos Santos, Hospital Sao Rafael
- Investigators
- Ricardo Ribeiro-dos-Santos, PhD, Principal investigator, Hospital São RafaelMilena BP Soares, PhD, Study director, Hospital São RafaelBruno SF Souza, MD, Msc, Study chair, Hospital São RafaelTiciana F Larocca, MD, Msc, Study chair, Hospital São RafaelRodrigo L Alves, MD, PhD, Study chair, Hospital São RafaelCarolina T Macedo, MD, MSc, Study chair, Hospital São RafaelAndré C Matos, MD, Study chair, Hospital São RafaelCristiane F Villarreal, PhD, Study chair, Hospital São Rafael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574585
- Sponsor's protocol ID
- SCI-005
- Status last verified
- Nov 2017
- First submitted
- 10 Apr 2015
- Last updated
- 28 Nov 2017
- 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 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for the Evaluation of Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02574585
- Acronym / sponsor ID
- SCI-005
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury, Paraplegia, Stem cells, Mesenchymal cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Sao RafaelUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 14 Oct 2015 (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 analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete spinal cord injury.
Detailed description
This is a randomized, non-placebo controlled, prospective, phase II clinical trial. The study population will consist of 40 patients who had spinal cord injury for at least 12 months, with thoracolumbar chronic and complete spinal cord injury, ASIA grade A.
A practitioner, a surgeon and a nurse will review the medical records of the patients to determine the presence / absence of inclusion / exclusion criteria. If the patient is a potential candidate for the study, an interview will be scheduled to review and confirm his/her eligibility. Patients will undergo a series of clinical and neurological assessments and will also be submitted to the following procedures:
- Cell blood count;
- Biochemical analysis (measurement of electrolytes - sodium, potassium, magnesium);
- Renal function tests (urea and creatinine);
- Liver function tests;
- Coagulation profile;
- Metabolic profile (glucose, total cholesterol and fractions);
- Urine summary and culture;
- Serology required for blood transfusion and marrow transplant in Brazil;
- Electrocardiogram;
- Chest X-Ray;
- Bone densitometry;
- Urodynamic studies;
- Somatosensory evoked potential;
- Computed tomography of thoracic and lumbar spine;
- Magnetic resonance imaging of the thoracic and lumbar spine.
Also as part of the preoperative evaluation, the patients will respond to questions from the SF (Short Form) -36 questionnaire (for assessment of quality of life) and the questionnaires for the assessment of neuropathic pain. Clinical follow-up will be kept for patients who suspend their participation in the study for any adverse event and / or laboratory abnormality, or for the patient's own desire, following insurance protocols. In addition to the clinical and surgical follow-up, specific medical care will be offered to patients who experience adverse events, until stabilization of the patient, even if the target date for completion of the study has been exceeded. The candidates included in the study will be asked to voluntarily participate and give their informed written consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | Experimental | Biological: Autologous mesenchymal cells transplantationTwenty subjects will be randomly assigned to receive two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections. |
| Control group | No intervention | –Twenty subjects will be randomly assigned to be clinically followed, without any specific intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Blunt spinal cord injury at thoracolumbar level, between T1 and L2, or penetrating spinal cord injury, at the same level, provided that the mechanism of injury had been spinal shock, ischemia or hematoma, with at least 12 months of injury;
- ASIA grade A;
- Signing of the written consent.
Key exclusion criteria (15 listed)
- Spinal cord injuries by sharp objects, firearms, and not traumatic or congenital causes, even if at different levels of the spinal cord;
- Concomitant brain injuries;
- Diabetes mellitus type 1 or 2 as defined by fasting glucose above 126 mg / use of medication and medical history;
- Infectious processes in acute and / or chronic course, confirmed by additional tests and / or medical history;
- Immunodeficiency, autoimmune diseases and neoplastic processes, confirmed by additional tests and / or medical history;
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 |
|---|---|---|
| Autologous mesenchymal cells transplantationTwo percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections. | Biological | Treated group |
Primary outcome
Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury
Time frame: 12 months
3 secondary outcomes
Functional improvement in ASIA (American Spinal Injury Association) grade
Time frame: 12 months
Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force)
Time frame: 12 months
Improvements in sensorial mapping and neuropathic pain
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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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.
Ricardo Ribeiro-dos-Santos, PhD principal investigator
Hospital São Rafael
Milena BP Soares, PhD study director
Hospital São Rafael
Bruno SF Souza, MD, Msc study chair
Hospital São Rafael
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous mesenchymal cells transplantation in people with Spinal Cord Injury, run by Hospital Sao Rafael.
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: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ricardo Ribeiro-dos-Santos, PhD (+557132816455, ricardoribeiro@cbtc-hsr.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury (time frame: 12 months). 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 28 Nov 2017.