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Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

14. května 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

10

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 70 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Autologous Mesenchymal Bone Marrow Cell
All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow Cell
Biologický: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Efficacy-Sensivity Improvement Using the ASIA Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Adverse Events .
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Puerta de Hierro University Hospital

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2014

Primární dokončení (Aktuální)

1. května 2016

Dokončení studie (Aktuální)

1. května 2016

Termíny zápisu do studia

První předloženo

6. května 2014

První předloženo, které splnilo kritéria kontroly kvality

12. června 2014

První zveřejněno (Odhad)

18. června 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. července 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. května 2019

Naposledy ověřeno

1. května 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CME-LEM2
  • 2011-005684-24 (Identifikátor registru: 2011-005684-24)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ano

Popis plánu IPD

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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