Spinal Cord InjuryNCT02152657
Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study
A study testing Mesenchymal stem cell transplantation in people with Spinal Cord Injury, run by Hospital Sao Rafael at 1 site in Brazil.
Trial summary
The purpose of this study is to analyze the safety and efficacy of mesenchymal stem cell transplantation through percutaneous injection in patients with chronic 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?
- Mesenchymal stem cell transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- 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
- Closed spinal cord injury at thoracic or thoracolumbar level bellow T8, or open spinal cord injury, at the same level, provided that the mechanism of the lesion is a spinal shock, ischemia or hematoma
- ASIA class A
- Signing the written consent
Who cannot join
- Anatomical transection of the spinal cord
- Spinal cord lesion by sharp objects
- Ongoing infections
- Terminal, neurodegenerative or primary hematological diseases
- Osteopathies which determine a higher risc to the bone marrow puncture
- Coagulopathies
Show all 11Show fewer
- Severe hepatic, renal or heart failure
- Pregnancy or lactation
- Clinical conditions that hinder the percutaneous injection of the cells such as arthrodesis
- Use of metallic implants near vascular structures (such as cardiac pacemaker or aortic prosthesis) which won't allow patients to perform MRI
- Participation in other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to analyze the safety and efficacy of mesenchymal stem cell transplantation through percutaneous injection in patients with chronic spinal cord injury.
Read the detailed description
This is a pilot, open, phase I study, in a prospective cohort. The study population will consist of 5 patients who had spinal cord injury for at least 6 months, with complete paraplegia.
A practitioner, a neurosurgeon and a nurse will review the medical records of 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 with the patient to review and confirm his/her eligibility. If the clinical eligibility is confirmed, the patient will undergo psychosocial evaluation to determine the degree of emotional equilibrium and conditions for participation in the study.
Patients will undergo a series of clinical and neurological evaluations 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 Brasil;
- Electrocardiogram;
- Chest X-Ray, X-ray of knees;
- Bone densitometry;
- Urodynamic studies;
- Somatosensory evoked potential;
- Computed tomography of thoracic and lumbar spine;
- MRI 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. Patients will be recruited for a minimum period of 06 months to follow up with additional laboratory and clinical examinations.
- Conditions
- Spinal Cord Injury
- Being tested
- Mesenchymal stem cell transplantation
- Keywords
- Spinal cord injury, Stem cell transplantation, Mesenchymal stem cell
- 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.
Mesenchymal stem cell transplantationOther
Mesenchymal stem cell transplantation through percutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell transplantation | Experimental | Not described Receives: Other: Mesenchymal stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic resonance imaging
After the transplantation of the cells, patients will be followed up by clinical examinations and will perform laboratorial and radiological exams, in order to search for complications of the procedure.
Measured: Six months
Secondary outcomes (3)
Sensitivity and motor strength on the inferior limbs
AIS (ASIA Improvement Scale) degree on the ASIA score will be assessed in order to evaluate sensitivity and motor strength on the inferior limbs.
Measured: Six months
Improvement in urological function
The patients will undergo urodynamic study to evaluate urological improvements.
Measured: Six 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: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2016
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Tomography-guided mesenchymal stem cells injection.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
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 R dos Santos, MD, 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 RafaelYuri MA Souza, MD, 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
- NCT02152657
- Sponsor's protocol ID
- SCI-002
- Status last verified
- Apr 2017
- First submitted
- 20 May 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study
- ClinicalTrials.gov ID
- NCT02152657
- Acronym / sponsor ID
- SCI-002
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury, Stem cell transplantation, Mesenchymal stem cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospital Sao RafaelUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Jun 2014 (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 mesenchymal stem cell transplantation through percutaneous injection in patients with chronic spinal cord injury.
Detailed description
This is a pilot, open, phase I study, in a prospective cohort. The study population will consist of 5 patients who had spinal cord injury for at least 6 months, with complete paraplegia.
A practitioner, a neurosurgeon and a nurse will review the medical records of 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 with the patient to review and confirm his/her eligibility. If the clinical eligibility is confirmed, the patient will undergo psychosocial evaluation to determine the degree of emotional equilibrium and conditions for participation in the study.
Patients will undergo a series of clinical and neurological evaluations 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 Brasil;
- Electrocardiogram;
- Chest X-Ray, X-ray of knees;
- Bone densitometry;
- Urodynamic studies;
- Somatosensory evoked potential;
- Computed tomography of thoracic and lumbar spine;
- MRI 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. Patients will be recruited for a minimum period of 06 months to follow up with additional laboratory and clinical examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Tomography-guided mesenchymal stem cells injection.
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell transplantation | Experimental | Other: Mesenchymal stem cell transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Closed spinal cord injury at thoracic or thoracolumbar level bellow T8, or open spinal cord injury, at the same level, provided that the mechanism of the lesion is a spinal shock, ischemia or hematoma
- ASIA class A
- Signing the written consent
Key exclusion criteria (11 listed)
- Anatomical transection of the spinal cord
- Spinal cord lesion by sharp objects
- Ongoing infections
- Terminal, neurodegenerative or primary hematological diseases
- Osteopathies which determine a higher risc to the bone marrow puncture
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 |
|---|---|---|
| Mesenchymal stem cell transplantationMesenchymal stem cell transplantation through percutaneous injection. | Other | Mesenchymal stem cell transplantation |
Primary outcome
Magnetic resonance imaging
Time frame: Six months
After the transplantation of the cells, patients will be followed up by clinical examinations and will perform laboratorial and radiological exams, in order to search for complications of the procedure.
3 secondary outcomes
Sensitivity and motor strength on the inferior limbs
Time frame: Six months
Improvement in urological function
Time frame: Six months
Improvements in sensorial mapping and neuropathic pain
Time frame: Six months
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 26 Apr 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 R dos Santos, MD, 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesenchymal stem cell transplantation in people with Spinal Cord Injury, run by Hospital Sao Rafael at 1 site in Brazil.
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 11 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 26 Apr 2017. 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 Brazil. 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.
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?
Magnetic resonance imaging (time frame: Six 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 26 Apr 2017.