Spinal Cord InjuriesPhase 2NCT05671796
Autologous Bone Marrow Stem Cell Transplantation in Patients With Subacute Spinal Cord Injury
A Phase 2 study testing Mesenchymal stem cell transplantation in people with Spinal Cord Injuries, run by SENAI CIMATEC at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the efficacy and safety of intrathecal administration of autologous mesenchymal stem cells in participants with subacute spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Mesenchymal stem cell transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2023to 1 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes over 18 years old;
- Closed or open spinal cord injury at the thoracic or lumbar level in the subacute phase (between 3 and 6 months after the event);
- ASIA A rating.
Who cannot join
- Section of the spinal anatomy;
- Active infectious diseases;
- Terminal patients;
- Neurodegenerative diseases;
- Primary hematologic diseases;
- Bone reflecting increased risk for spinal puncture;
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- Coagulopathies;
- Hepatic dysfunction;
- Pregnancy;
- Other medical complications that contraindicate surgery, including major respiratory complications;
- Participation in another clinical trial;
- Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate magnetic resonance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2, Double- Blind, Placebo- Controlled , Randomized Clinical Trial of Autologous Bone Marrow Stem Cell Transplantation in Patients With Subacute Spinal Cord Injury
The aim of this study is to evaluate the efficacy and safety of intrathecal administration of autologous mesenchymal stem cells in participants with subacute spinal cord injury.
Read the detailed description
Spinal cord injury (SCI) constitutes a social and economic problem with the aggravating factor of being able to limit individual capacity, leading to a condition of unproductiveness and incapacity. At present, there is no effective treatment for recovering an injured spinal cord. Our research group was one of the pioneers in the study of mesenchymal stem cell therapies in the treatment of SCI, having carried out preclinical studies, as well as clinical studies with participants with complete spinal cord injuries, which demonstrated that stem cell transplantation mesenchymal (MSC) from autologous bone marrow was a safe and effective therapy in these studies. This project proposes the investigation of this therapy in participants with complete spinal cord injuries in the thoracolumbar region, in the subacute phase (defined between 3 to 6 months after the event), aiming to evaluate the safety and efficacy of the injection of mesenchymal stem cells. For this, we propose a double-blind, randomized clinical study to demonstrate the efficacy and safety of bone marrow MSC transplantation in participants with complete paraplegia, classified by ASIA Impairment Scale (AIS) grade A, by TRM, with subacute lesion. Forty participants will be referred by reference institutions and then recruited to be subsequently subjected to randomization, if eligible, with a group of 20 participants treated by intrathecal infusion of autologous MSCs, and another of 20 participants allocated to the control group, using a glucophysiological solution as a subcutaneous placebo. Each participant, after recruitment, will be monitored for a period of approximately 01 (one) year. The preparation of the CTMs will be done in accordance with the standards of good manufacturing practices. Both groups participating in the study will be submitted to pre- and post-treatment evaluations. The effectiveness of the therapy will be evaluated using the scale established by ASIA (American Spinal Injury Association) and the International Classification of Functioning, Disability and Health (ICF).
- Conditions
- Spinal Cord Injuries
- Being tested
- Mesenchymal stem cell transplantation, Placebo
- Keywords
- Spinal cord injury, Mesenchymal stem cells, Bone marrow
- 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 transplantationGenetic
Patients will undergo two autologous bone marrow stem cell transplantation into the lesion area
PlaceboOther
Patients will undergo two subcutaneous injections of 1 ml of glycophysiological solution into the lesion area by sham procedure
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell transplantation | Experimental | Two intrathecal autologous bone marrow stem cell transplantation of 1 ml solution containing 5x10,000,000 MSCs each with a 90-day interval between applications. Receives: Genetic: Mesenchymal stem cell transplantation |
| Placebo | Placebo comparator | Two subcutaneous injections of 1 ml each, containing glycophysiological solution.with a 90-day interval between applications. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline ASIA scale and 12 Months after autologous mesenchymal stem cells transplantation in individuals with subacute spinal cord injury
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), commonly referred to as the ASIA Exam, was developed by the American Spinal Injury Association (ASIA) as a universal classification tool for spinal cord injuries based on a standardized sensory and motor assessment.It involves both a Motor and Sensory examination to determine the Sensory Level and Motor Level for each side of the body (Right and Left), the single Neurological Level of Injury (NLI) and whether the injury is Complete or Incomplete. Elements of the scale include: Grade A: The impairment is complete, Grade B ,C and D: The impairment is incomplete with some differences between them.;Grade E: The patient's functions are normal
Measured: Baseline and 12 months
Secondary outcomes (5)
Change from Baseline AIS scale and 12 Months after autologous mesenchymal stem cells transplantation
American Spinal Injury Association Impairment Scale (AIS) is a standardized neurological examination used by the rehabilitation team to assess the sensory and motor levels which were affected by the spinal cord injury. The scale has five classification levels, ranging from complete loss of neural function in the affected area to completely normal. The results help the team set functional goals based on the neurological level of injury that is determined. Elements of the scale include: Grade A: The impairment is complete, Grade B ,C and D: The impairment is incomplete with some differences between them.;Grade E: The patient's functions are normal.
Measured: Baseline and 12 months
Improvement in quality of life, measured by the WhoQof-bref Questionnaire.
The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale
Measured: Baseline, 1 month, 6 months and 12 months
Assessment of neuropathic pain by McGill Pain Questionnaire
McGill Pain Questionnaire (MPQ) is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is a multi-dimesional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain.
Measured: Baseline, 1 month, 6 months and 12 months
Assessment sensory impairment after subacute spinal cord injury with von Frey filaments
The mechanical sensitivity (Von Frey) test consists of thin calibrated plastic filaments that are applied to the plantar surface. Von Frey filaments of different gauges or stiffness are used to determine the threshold that elicits a hind paw withdrawal response. The mechanical withdrawal threshold is defined as the minimum gauge Von Frey filament that elicits a withdrawal reflex. The purpose of this test is to measure mechanical nociception in order to valuates the ability to detect a noxious stimulus.
Measured: Baseline, 1 month, 6 months and 12 months
Assessment sensory impairment after subacute spinal cord injury with Quantitative Sensory Test
Quantitative sensory testing (QST) refers to psychophysical tests of sensory perception during the administration of stimuli with predetermined physical properties and following specific protocols. QST is able to capture and quantify stimulus-evoked negative and positive sensory phenomena,
Measured: Baseline, 1 month, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Apr 2023 (estimated)
- Primary completion25 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SENAI CIMATEC
- Sponsor type
- University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation, Federal University of Bahia, Hospital Geral do Estado, Hospital da Bahia
- Responsible party
- Sponsor
- Investigators
- Milena Soares, PhD, Study director, SENAI CIMATECAugusto Mota, PhD, Principal investigator, Hospital da Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671796
- Sponsor's protocol ID
- PLC01/2021
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Double- Blind, Placebo- Controlled , Randomized Clinical Trial of Autologous Bone Marrow Stem Cell Transplantation in Patients With Subacute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05671796
- Acronym / sponsor ID
- PLC01/2021
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injury, Mesenchymal stem cells, Bone marrow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SENAI CIMATECUniversity, hospital or other
- Collaborators
- Oswaldo Cruz Foundation, Federal University of Bahia, Hospital Geral do Estado, Hospital da Bahia
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 25 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Jan 2023 (actual)
- 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 aim of this study is to evaluate the efficacy and safety of intrathecal administration of autologous mesenchymal stem cells in participants with subacute spinal cord injury.
Detailed description
Spinal cord injury (SCI) constitutes a social and economic problem with the aggravating factor of being able to limit individual capacity, leading to a condition of unproductiveness and incapacity. At present, there is no effective treatment for recovering an injured spinal cord. Our research group was one of the pioneers in the study of mesenchymal stem cell therapies in the treatment of SCI, having carried out preclinical studies, as well as clinical studies with participants with complete spinal cord injuries, which demonstrated that stem cell transplantation mesenchymal (MSC) from autologous bone marrow was a safe and effective therapy in these studies. This project proposes the investigation of this therapy in participants with complete spinal cord injuries in the thoracolumbar region, in the subacute phase (defined between 3 to 6 months after the event), aiming to evaluate the safety and efficacy of the injection of mesenchymal stem cells. For this, we propose a double-blind, randomized clinical study to demonstrate the efficacy and safety of bone marrow MSC transplantation in participants with complete paraplegia, classified by ASIA Impairment Scale (AIS) grade A, by TRM, with subacute lesion. Forty participants will be referred by reference institutions and then recruited to be subsequently subjected to randomization, if eligible, with a group of 20 participants treated by intrathecal infusion of autologous MSCs, and another of 20 participants allocated to the control group, using a glucophysiological solution as a subcutaneous placebo. Each participant, after recruitment, will be monitored for a period of approximately 01 (one) year. The preparation of the CTMs will be done in accordance with the standards of good manufacturing practices. Both groups participating in the study will be submitted to pre- and post-treatment evaluations. The effectiveness of the therapy will be evaluated using the scale established by ASIA (American Spinal Injury Association) and the International Classification of Functioning, Disability and Health (ICF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell transplantation | Experimental | Genetic: Mesenchymal stem cell transplantationTwo intrathecal autologous bone marrow stem cell transplantation of 1 ml solution containing 5x10,000,000 MSCs each with a 90-day interval between applications. |
| Placebo | Placebo comparator | Other: PlaceboTwo subcutaneous injections of 1 ml each, containing glycophysiological solution.with a 90-day interval between applications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both sexes over 18 years old;
- Closed or open spinal cord injury at the thoracic or lumbar level in the subacute phase (between 3 and 6 months after the event);
- ASIA A rating.
Key exclusion criteria (12 listed)
- Section of the spinal anatomy;
- Active infectious diseases;
- Terminal patients;
- Neurodegenerative diseases;
- Primary hematologic diseases;
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 transplantationPatients will undergo two autologous bone marrow stem cell transplantation into the lesion area | Genetic | Mesenchymal stem cell transplantation |
| PlaceboPatients will undergo two subcutaneous injections of 1 ml of glycophysiological solution into the lesion area by sham procedure | Other | Placebo |
Primary outcome
Change from Baseline ASIA scale and 12 Months after autologous mesenchymal stem cells transplantation in individuals with subacute spinal cord injury
Time frame: Baseline and 12 months
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), commonly referred to as the ASIA Exam, was developed by the American Spinal Injury Association (ASIA) as a universal classification tool for spinal cord injuries based on a standardized sensory and motor assessment.It involves both a Motor and Sensory examination to determine the Sensory Level and Motor Level for each side of the body (Right and Left), the single Neurological Level of Injury (NLI) and whether the injury is Complete or Incomplete. Elements of the scale include: Grade A: The impairment is complete, Grade B ,C and D: The impairment is incomplete with some differences between them.;Grade E: The patient's functions are normal
5 secondary outcomes
Change from Baseline AIS scale and 12 Months after autologous mesenchymal stem cells transplantation
Time frame: Baseline and 12 months
Improvement in quality of life, measured by the WhoQof-bref Questionnaire.
Time frame: Baseline, 1 month, 6 months and 12 months
Assessment of neuropathic pain by McGill Pain Questionnaire
Time frame: Baseline, 1 month, 6 months and 12 months
Assessment sensory impairment after subacute spinal cord injury with von Frey filaments
Time frame: Baseline, 1 month, 6 months and 12 months
Assessment sensory impairment after subacute spinal cord injury with Quantitative Sensory Test
Time frame: Baseline, 1 month, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- 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.
Milena Soares, PhD study director
SENAI CIMATEC
Augusto Mota, PhD principal investigator
Hospital da Bahia
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 Mesenchymal stem cell transplantation in people with Spinal Cord Injuries, run by SENAI CIMATEC 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 12 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 12 Jan 2023. 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. Some participants in this study may receive a placebo. 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 Carolina Macedo, PhD (557138795574, carolthemacedo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline ASIA scale and 12 Months after autologous mesenchymal stem cells transplantation in individuals with subacute spinal cord injury (time frame: Baseline and 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 12 Jan 2023.