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Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

14 mei 2019 bijgewerkt door: Jesús Vaquero Crespo, M.D., Puerta de Hierro University Hospital

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

10

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Spanje
    • Madrid
      • Majadahonda, Madrid, Spanje, 28222
        • Hospital Puerta de Hierro

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Incomplete SCI
  2. Neurological deficit clinically stable at least 12 months prior to treatment, and with a minimum of one-year evolution after SCI.
  3. Neurophysiological confirmation of incomplete SCI.
  4. The MRI study that morphologically evaluate the SCI.
  5. Age between 18 and 70 years
  6. Thread Men and women will compromise to use anticonceptive issues from first cell´s extraction to 6 months after last cell´s administration.
  7. Ability to attend clinical follow-up and perform physical therapy through the treatment period.
  8. Written and signed informed consent, according to the local regulation.
  9. 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.

Exclusion Criteria:

  1. A classification in ASIA and FRANKEL clinical scales to evaluate the SCI.
  2. Neurophysiological records that confirm the complete SCI.
  3. Age below 18 years or above 70.
  4. Pregnancy or lactation.
  5. Malignancy disease diagnosed or treated within the last 5 years.
  6. Patients with systemic disease that represents and additional risk to treatment.
  7. 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.
  8. Inability to assess the SCI features through MRI either noise due to spinal stabilization systems or any other cause.
  9. Patients currently under hematopoietic growth factors treatment or who required or maintained anticoagulation.
  10. Neurodegenerative disease additional.
  11. History of substance abuse, psychiatric disease or allergy to the protein products used in the process of cell expansion.
  12. Positive serology for HIV and syphilis.
  13. Active Hepatitis B or Hepatitis C.
  14. With other reason that would consider the patient ineligible for cell therapy according to the investigators judgment.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Autologous Mesenchymal Bone Marrow Cell
All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow Cell
Biologisch: Adult Autologous Mesenchymal Bone Marrow Cell
Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Efficacy-Sensivity Improvement Using the ASIA Score
Tijdsspanne: measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery
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.
measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery
Efficacy- Changes in Functional Independence Measure Scale
Tijdsspanne: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

- 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.
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
Efficacy-Change in Barthel Score
Tijdsspanne: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

- 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.
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
Efficacy-IANC-SCIFRS Scale
Tijdsspanne: Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)

-Changes in IANC-SCIFRS scale

Ranges score: 0 to 48. Being 0 severe degree of disability and 48 normal value.
Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
Efficacy-Changes in PENN Score.
Tijdsspanne: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

- 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.
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
Changes in ASHWORTH Score
Tijdsspanne: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

- 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
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
Efficacy-Changes in EVA Score
Tijdsspanne: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

• 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.
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
Efficacy- Changes in Geffner Score
Tijdsspanne: Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)

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
Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
Efficacy- Changes in NBD Score
Tijdsspanne: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

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.
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)
Tijdsspanne: Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study.
Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
Efficacy-Urodynammic in Terms of Detrusor Pressure
Tijdsspanne: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)
Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
Efficacy-Urodynamic Studies Bladder Compliance
Tijdsspanne: measure before treatment (baseline visit), 6 and 12 months after surgery

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.
measure before treatment (baseline visit), 6 and 12 months after surgery
Efficacy-Urodynamic Studies Maximum Cystometric Capacity
Tijdsspanne: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
Urodynamic studies in terms of Maximum cystometric capacity
Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
Efficacy-modification of Magnetic Resonance Imaging (MRI)
Tijdsspanne: before (baseline visit) and at 12 months
Number of patients with changes in morphology of injury compared with basal images
before (baseline visit) and at 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Adverse Events .
Tijdsspanne: Up to 12 months
- 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).
Up to 12 months
Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples
Tijdsspanne: Basal and 10 months after the administration
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.
Basal and 10 months after the administration

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Puerta de Hierro University Hospital

Onderzoekers

  • Hoofdonderzoeker: Jesús JV Vaquero Crespo, M.D., Hospital Universitario Puerta de Hierro-Majadahonda

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2014

Primaire voltooiing (Werkelijk)

1 mei 2016

Studie voltooiing (Werkelijk)

1 mei 2016

Studieregistratiedata

Eerst ingediend

6 mei 2014

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2014

Eerst geplaatst (Schatting)

18 juni 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 juli 2019

Laatste update ingediend die voldeed aan QC-criteria

14 mei 2019

Laatst geverifieerd

1 mei 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CME-LEM2
  • 2011-005684-24 (Register-ID: 2011-005684-24)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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