Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

tiistai 14. toukokuuta 2019 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

10

Vaihe

  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 70 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Autologous Mesenchymal Bone Marrow Cell
All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow Cell
Biologinen: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Efficacy-Sensivity Improvement Using the ASIA Score
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Adverse Events .
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Puerta de Hierro University Hospital

Tutkijat

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

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Torstai 1. toukokuuta 2014

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 1. toukokuuta 2016

Opintojen valmistuminen (Todellinen)

Sunnuntai 1. toukokuuta 2016

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 6. toukokuuta 2014

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 12. kesäkuuta 2014

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 18. kesäkuuta 2014

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 19. heinäkuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 14. toukokuuta 2019

Viimeksi vahvistettu

Keskiviikko 1. toukokuuta 2019

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • CME-LEM2
  • 2011-005684-24 (Rekisterin tunniste: 2011-005684-24)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

Joo

IPD-suunnitelman kuvaus

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

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa