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Spinal Cord InjuryPhase 1NCT02165904

Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

A Phase 1 study testing Adult Autologous Mesenchymal Bone Marrow Cell in people with Spinal Cord Injury, run by Puerta de Hierro University Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study goes on 24 months, with recruiting, treatment and follow period for all patients. The first day for each patient will be the first cellular administration. 3 doses will be administrated every 3 months from first dose. 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?
Adult Autologous Mesenchymal Bone Marrow Cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSpain
Study dates
May 2014to May 2016
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Incomplete SCI
  • Neurological deficit clinically stable at least 12 months prior to treatment, and with a minimum of one-year evolution after SCI.
  • Neurophysiological confirmation of incomplete SCI.
  • The MRI study that morphologically evaluate the SCI.
  • Age between 18 and 70 years
  • Thread Men and women will compromise to use anticonceptive issues from first cell´s extraction to 6 months after last cell´s administration.
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  • Ability to attend clinical follow-up and perform physical therapy through the treatment period.
  • Written and signed informed consent, according to the local regulation.
  • Hematologic and creatinin parameters, SGOT and SGPT, within the normal range, according to laboratory standards considering that small variations could be accepted based on clinical study team criteria.

Who cannot join

  • A classification in ASIA and FRANKEL clinical scales to evaluate the SCI.
  • Neurophysiological records that confirm the complete SCI.
  • Age below 18 years or above 70.
  • Pregnancy or lactation.
  • Malignancy disease diagnosed or treated within the last 5 years.
  • Patients with systemic disease that represents and additional risk to treatment.
Show all 14Show fewer
  • Patients with uncertain commitment to follow the physical therapy and clinical visits as well as patient with a negative input in the previous phycological assessment.
  • Inability to assess the SCI features through MRI either noise due to spinal stabilization systems or any other cause.
  • Patients currently under hematopoietic growth factors treatment or who required or maintained anticoagulation.
  • Neurodegenerative disease additional.
  • History of substance abuse, psychiatric disease or allergy to the protein products used in the process of cell expansion.
  • Positive serology for HIV and syphilis.
  • Active Hepatitis B or Hepatitis C.
  • With other reason that would consider the patient ineligible for cell therapy according to the investigators judgment.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Puerta de Hierro

    Majadahonda, Madrid, 28222

Other trials in Spain

About this study

Official title: Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in Patients Suffering Incomplete Spinal Cord Injury (SCI)

The study goes on 24 months, with recruiting, treatment and follow period for all patients. The first day for each patient will be the first cellular administration. 3 doses will be administrated every 3 months from first dose.

When the clinical trial finishes, it will be done a completed check of all obtained parameters.

Read the detailed description

It is a clinical trial phase I, single center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury (SCI) .10 patients will be included with this injury.

Primary objective: Analyze the possible clinical efficacy of administration of main adult mesenchymal autologous cells expanded "in vitro" in patients with incomplete and chronically established SCI.

Secondary objectives: Confirm the safety of treatment, and study possible changes in the cerebrospinal fluid (CSF) levels (Brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), nerve growth factor (NGF), ciliary neurotrophic factor (CNTF), Nerve Growth Factor 3 and 4(NT3 and NT4) after subarachnoid administration of BMMC.

Being tested
Adult Autologous Mesenchymal Bone Marrow Cell
Keywords
Analyze clinical efficacy of subarachnoid administration of, autologous BMSC expanded "in vitro"
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.

  • Adult Autologous Mesenchymal Bone Marrow CellBiological

    Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells.

Study groups in NCT02165904
Study groupRoleWhat they receive
Autologous Mesenchymal Bone Marrow CellExperimentalAll patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow Cell
Receives: Biological: Adult Autologous Mesenchymal Bone Marrow Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy-Sensivity Improvement Using the ASIA Score

    Sensitivity improvement was measured using the ASIA (American Spinal Injury Association) scale to measure the Surface sensitivity (LTS), pain sensitivity (PPS), and the degree of motor function in key muscles (MS). The sum of MS, LTS, and PPS configure total ASIA score. A minimum possible score is 0 points. A maximum possible score is 224 points for a patient with normal sensation. ASIA score was obtained before surgery, and 3, 6, 9 and 12 months after surgery. Mean and standard deviation for the 10 patients were obtained at all the time points and statistically analyzed.

    Measured: measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery

  2. Efficacy- Changes in Functional Independence Measure Scale

    • Changes in Functional Independence Measure scale (NIF scale), score at the beginning, through and the end of the treatment.

    Ranges score: 18 to 126. Being 18 total patient dependency and 126 total patient independence.

    Measured: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

  3. Efficacy-Change in Barthel Score

    • Changes in Barthel score at the beginning, through and the end of the treatment.

    Ranges score: 0 to 100. Being 0 total patient dependency and 100 total patient independence.

    Measured: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

  4. Efficacy-IANC-SCIFRS Scale

    -Changes in IANC-SCIFRS scale

    Ranges score: 0 to 48. Being 0 severe degree of disability and 48 normal value.

    Measured: Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)

  5. Efficacy-Changes in PENN Score.

    • Changes in PENN score at the beginning, through and the end of the treatment

    Ranges score: 0 to 4. Being 0 absence of spasms and 4 frequency greater than 10 spasms per hour.

    Measured: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

  6. Changes in ASHWORTH Score

    • Changes in ASHWORTH score at the beginning, through and the end of the treatment

    Ranges score: 0 to 4. Being 0 when there isn´t increase in muscle tone when stretching, and 4 when there is rigid affected follow-up in flexion or extension

    Measured: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

  7. Efficacy-Changes in EVA Score

    • Changes in EVA score at the beginning, through and the end of the treatment

    Ranges score: 0 to 10. Being 0 absence of pain and 10 the worst pain.

    Measured: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

  8. Efficacy- Changes in Geffner Score

    changes in Geffner score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)

    Ranges score: 0 to 6. Being 0 absence of bladder control and 6 total control of bladder

    Measured: Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)

  9. Efficacy- Changes in NBD Score

    changes in NBD score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)

    Ranges score: 0 to 47. 0-6 is very minor dysfunction. 7-9 is minor dysfunction. 10-13 is moderate dysfunction; and 14 or more is severe dysfunction.

    Measured: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

  10. Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)

    Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study.

    Measured: Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery

  11. Efficacy-Urodynammic in Terms of Detrusor Pressure

    Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)

    Measured: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up

  12. Efficacy-Urodynamic Studies Bladder Compliance

    Urodynamic studies in terms of Bladder compliance. Bladder compliance is the result of a mathematical calculation of volume responsible for 1 cm H2O pressure rise measured during a cystometric filling

    . It gives an indication on how the different mechanisms in the bladder wall react on stretching.

    It is obvious that compliance figures can vary widely in groups which makes it difficult to define limits of normality.

    Measured: measure before treatment (baseline visit), 6 and 12 months after surgery

  13. Efficacy-Urodynamic Studies Maximum Cystometric Capacity

    Urodynamic studies in terms of Maximum cystometric capacity

    Measured: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up

  14. Efficacy-modification of Magnetic Resonance Imaging (MRI)

    Number of patients with changes in morphology of injury compared with basal images

    Measured: before (baseline visit) and at 12 months

Secondary outcomes (2)

  1. Number of Adverse Events .

    • The safety will be valued with number of adverse events related with administration of subarachnoid autologous Bone Marrow Expanded Mesenchymal Cells in Incomplete Spinal Cord Injury (SCI).

    Measured: Up to 12 months

  2. Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples

    Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophins were: BDNF.

    Measured: Basal and 10 months after the administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02165904
Sponsor's protocol ID
CME-LEM2
Other IDs
2011-005684-24
Status last verified
May 2019
First submitted
6 May 2014
Last updated
19 Jul 2019
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

Publications

  • Vaquero J, Zurita M. Functional recovery after severe CNS trauma: current perspectives for cell therapy with bone marrow stromal cells. Prog Neurobiol. 2011 Mar;93(3):341-9. doi: 10.1016/j.pneurobio.2010.12.002. Epub 2010 Dec 14.

    PubMed 21163325

  • Otero L, Zurita M, Bonilla C, Aguayo C, Vela A, Rico MA, Vaquero J. Late transplantation of allogeneic bone marrow stromal cells improves neurologic deficits subsequent to intracerebral hemorrhage. Cytotherapy. 2011 May;13(5):562-71. doi: 10.3109/14653249.2010.544720. Epub 2011 Jan 5.

    PubMed 21208021

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Adult 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 9 inclusion and 14 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 19 Jul 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Efficacy-Sensivity Improvement Using the ASIA Score (time frame: measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery). The study lists 14 primary outcomes in all. 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 NCT02165904, which also lists 2 linked publications.

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 19 Jul 2019.

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