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Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

2019年5月14日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

10

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • スペイン
    • Madrid
      • Majadahonda、Madrid、スペイン、28222
        • Hospital Puerta de Hierro

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Autologous Mesenchymal Bone Marrow Cell
All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow Cell
生物学的：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Efficacy-Sensivity Improvement Using the ASIA Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Adverse Events .
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Puerta de Hierro University Hospital

捜査官

  • 主任研究者：Jesús JV Vaquero Crespo, M.D.、Hospital Universitario Puerta de Hierro-Majadahonda

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年5月1日

一次修了 (実際)

2016年5月1日

研究の完了 (実際)

2016年5月1日

試験登録日

最初に提出

2014年5月6日

QC基準を満たした最初の提出物

2014年6月12日

最初の投稿 (見積もり)

2014年6月18日

学習記録の更新

投稿された最後の更新 (実際)

2019年7月19日

QC基準を満たした最後の更新が送信されました

2019年5月14日

最終確認日

2019年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CME-LEM2
  • 2011-005684-24 (レジストリ識別子：2011-005684-24)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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