Spinal Cord InjuryPhase 2NCT02570932
Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries
A Phase 2 study testing Autologous Mesenchymal Bone Marrow Cell in people with Spinal Cord Injury, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
The purpose of this study is to analyze the potential clinical efficacy of intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal stem cells in the treatment of patients with established chronic spinal cord injury (LEM). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Autologous Mesenchymal Bone Marrow Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to 4 Dec 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury (Level A, B, C or D in ASIA scales), clinically stable for at least 6 months prior to study start.
- Previous studies of Neurophysiology, MRI and Urology to allow useful baseline, in order that they can be compared with the same scans following treatment, and to obtain objective data of potential efficacy.
- Age between 18 and 70 years.
- Men and women of childbearing age must compromise to use contraceptives from the time at which the removal of cells from the bone marrow is performed until 6 months after the Mesenchymal Stem Cells (MSC) last administration by lumbar puncture.
- Possibility of follow up and ability to perform ambulatory physical therapy throughout all treatment period.
- Written informed consent, according to the law in force.
- Hematologic, creatinine, Serum glutamic oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) parameters, within the normal range, according to laboratory standards. However, slight modifications that are considered significant in the context of treatment to be performed, according to the criterion of the research team, are accepted.
Who cannot join
- Age below 18 years or above 70.
- Pregnancy or lactation.
- Current neoplastic disease or in the previous 5 years (diagnosed or treated).
- Patients with systemic disease that represents an added risk to treatment.
- Alterations in the genetic study performed to discard risk cell transformation in the expansion process.
- Patients with doubts about possible cooperation in the maintenance physical therapy or in the controls carried out during the study
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- Neurodegenerative disease added.
- History of substance abuse, psychiatric disease or allergy to protein products used in the process of cell expansion.
- Positive serology for HIV and syphilis.
- Active Hepatitis B or Hepatitis C, according to serology analysis.
- If in the opinion of the researcher there is some other reason why the patient is not considered candidate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Administration (Pattern 100/3) of Expanded Autologous Adult Bone Marrow Mesenchymal Stem Cells in Established Chronic Spinal Cord Injuries
The purpose of this study is to analyze the potential clinical efficacy of intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal stem cells in the treatment of patients with established chronic spinal cord injury (LEM).
Read the detailed description
This is a clinical trial phase II, single-center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury.
Patients are treated with repeated administrations of in vitro expanded autologous adult bone marrow mesenchymal stem cells.
The expanded cells are administered in the subarachnoid space by lumbar puncture. The minimum duration of the follow-up period for each patient is 10 months after the first administration.
The study duration is 24 months, that include recruiting, treatment and follow period for all patients. For each patient at the first day will be administered the first cellular doses, then 3 doses will be administrated every 3 months. At the end of the clinical trial, a completed check of all obtained parameters will be performed.
It is considered Day 1 for each patient the first day of the first cell administration. The remaining 2 doses will be administered at intervals of 3 months from the first administration (of the treatment period after, months 4 and 7). At the end of the study will be performed a full assessment of the variables collected along the study trial.
- Conditions
- Spinal Cord Injury
- Being tested
- Autologous Mesenchymal Bone Marrow Cell
- Keywords
- Adult Autologous Bone Marrow Mesenchymal Cells Expanded, chronic spinal cord injury (SCI)
- 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.
Autologous Mesenchymal Bone Marrow CellBiological
Suspension in autologous plasma cell of Adult mesenchymal stem cells expanded autologous bone marrow.
Route of administration: Intrathecal in subarachnoid space by lumbar puncture.Total dose of 300 x 106 CME, divided in 3 injections of 100 x 106 CME, with intervals of three months between each administration
| Study group | Role | What they receive |
|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Experimental | All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow expanded Stem Cell (CME)
Pharmaceutical form: Suspension in autologous plasma cell Route of administration: Intrathecal in subarachnoid space by lumbar puncture. Dose: Total dose of 300 x 106 CME, given in 3 injections of 100 x 106 CME, at intervals of 3 months between each administration. Receives: Biological: Autologous Mesenchymal Bone Marrow Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in IANR-SCIFRS score are considerate for the motor and sensory functions evaluation.
Efficacy evaluation by measuring the change in motor and sensory functions by using the international Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS). This scale includes 9 categories with 16 items in total (plus one optional category).
The maximum possible score is 48; the lowest possible score is 0.
Measured: from baseline until the end of the follow up period (24 months)
Secondary outcomes (5)
Neurotrophic factors levels in Cerebrospinal fluid (CSF) and/ or Number of Adverse Events related to treatment
The clinical evaluation of possible adverse effects is performed throughout the entire study duration and will be measured by descriptive analysis
Measured: from baseline to 24 months
Changes in PENN score are considerate for the motor and sensory functions evaluation
Efficacy evaluation by measuring the change in motor and sensory functions by using the Penn Spasm Frequency Scale that is Composed of 2-parts: the first is a self-report measure with items on 5-point scales developed to augment clinical ratings of spasticity and provides a more comprehensive assessment of spasticity
Measured: from baseline until the end of the follow up period (24 months)
Changes in VAS score are considerate for quantification of pain
Efficacy evaluation by measuring the change in pain by using the visual analogue scale (VAS). The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks, depending on his feel of pain.
Measured: from baseline until the end of the follow up period (24 months)
Changes in BDS score are considerate for the Assessment of the functional status
Efficacy evaluation by measuring the change in the Blepharospasm Disability Scale (BDS)
Measured: from baseline until the end of the follow up period (24 months)
Changes in GEFFNER score are considerate for the Assessment of the functional status
Efficacy evaluation by measuring the change in the GEFFNER score
Measured: from baseline until the end of the follow up period (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startJul 2015
- Primary completion4 Dec 2017
- Study completion4 Dec 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital
- Investigators
- Jesús JV Vaquero Crespo, MD., Principal investigator, Hospital Universitario Puerta de Hierro Majadahonda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570932
- Sponsor's protocol ID
- CME-LEM3
- Other IDs
- 2014-005613-24, 2014
- Status last verified
- Apr 2018
- First submitted
- 2 Oct 2015
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual data of participants will be shared with Authorities at the end of the Clinical development plan by the CTD (Common Technical Document). Results will be published in a scientific publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Administration (Pattern 100/3) of Expanded Autologous Adult Bone Marrow Mesenchymal Stem Cells in Established Chronic Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT02570932
- Acronym / sponsor ID
- CME-LEM3
- Conditions
- Spinal Cord Injury
- Keywords
- Adult Autologous Bone Marrow Mesenchymal Cells Expanded, chronic spinal cord injury (SCI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 7 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 potential clinical efficacy of intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal stem cells in the treatment of patients with established chronic spinal cord injury (LEM).
Detailed description
This is a clinical trial phase II, single-center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury.
Patients are treated with repeated administrations of in vitro expanded autologous adult bone marrow mesenchymal stem cells.
The expanded cells are administered in the subarachnoid space by lumbar puncture. The minimum duration of the follow-up period for each patient is 10 months after the first administration.
The study duration is 24 months, that include recruiting, treatment and follow period for all patients. For each patient at the first day will be administered the first cellular doses, then 3 doses will be administrated every 3 months. At the end of the clinical trial, a completed check of all obtained parameters will be performed.
It is considered Day 1 for each patient the first day of the first cell administration. The remaining 2 doses will be administered at intervals of 3 months from the first administration (of the treatment period after, months 4 and 7). At the end of the study will be performed a full assessment of the variables collected along the study trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Experimental | Biological: Autologous Mesenchymal Bone Marrow CellAll patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow expanded Stem Cell (CME) Pharmaceutical form: Suspension in autologous plasma cell Route of administration: Intrathecal in subarachnoid space by lumbar puncture. Dose: Total dose of 300 x 106 CME, given in 3 injections of 100 x 106 CME, at intervals of 3 months between each administration. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Spinal cord injury (Level A, B, C or D in ASIA scales), clinically stable for at least 6 months prior to study start.
- Previous studies of Neurophysiology, MRI and Urology to allow useful baseline, in order that they can be compared with the same scans following treatment, and to obtain objective data of potential efficacy.
- Age between 18 and 70 years.
- Men and women of childbearing age must compromise to use contraceptives from the time at which the removal of cells from the bone marrow is performed until 6 months after the Mesenchymal Stem Cells (MSC) last administration by lumbar puncture.
- Possibility of follow up and ability to perform ambulatory physical therapy throughout all treatment period.
Key exclusion criteria (11 listed)
- Age below 18 years or above 70.
- Pregnancy or lactation.
- Current neoplastic disease or in the previous 5 years (diagnosed or treated).
- Patients with systemic disease that represents an added risk to treatment.
- Alterations in the genetic study performed to discard risk cell transformation in the expansion process.
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 Bone Marrow CellSuspension in autologous plasma cell of Adult mesenchymal stem cells expanded autologous bone marrow. Route of administration: Intrathecal in subarachnoid space by lumbar puncture.Total dose of 300 x 106 CME, divided in 3 injections of 100 x 106 CME, with intervals of three months between each administration | Biological | Autologous Mesenchymal Bone Marrow Cell |
Primary outcome
Changes in IANR-SCIFRS score are considerate for the motor and sensory functions evaluation.
Time frame: from baseline until the end of the follow up period (24 months)
Efficacy evaluation by measuring the change in motor and sensory functions by using the international Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS). This scale includes 9 categories with 16 items in total (plus one optional category). The maximum possible score is 48; the lowest possible score is 0.
5 secondary outcomes
Neurotrophic factors levels in Cerebrospinal fluid (CSF) and/ or Number of Adverse Events related to treatment
Time frame: from baseline to 24 months
Changes in PENN score are considerate for the motor and sensory functions evaluation
Time frame: from baseline until the end of the follow up period (24 months)
Changes in VAS score are considerate for quantification of pain
Time frame: from baseline until the end of the follow up period (24 months)
Changes in BDS score are considerate for the Assessment of the functional status
Time frame: from baseline until the end of the follow up period (24 months)
Changes in GEFFNER score are considerate for the Assessment of the functional status
Time frame: from baseline until the end of the follow up period (24 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 5 Apr 2018.
- Individual participant dataSharing planned: Yes. Anonymized individual data of participants will be shared with Authorities at the end of the Clinical development plan by the CTD (Common Technical Document). Results will be published in a scientific publication
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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.
Jesús JV Vaquero Crespo, MD. principal investigator
Hospital Universitario Puerta de Hierro Majadahonda
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 Autologous Mesenchymal Bone Marrow Cell in people with Spinal Cord Injury, run by Puerta de Hierro University Hospital at 1 site in Spain.
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 7 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 5 Apr 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 Spain. 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?
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?
Changes in IANR-SCIFRS score are considerate for the motor and sensory functions evaluation. (time frame: from baseline until the end of the follow up period (24 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 5 Apr 2018.