Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries

NCT02570932 | Completed Phase 2

• 2 other identifiers: CME-LEM32014-005613-24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze the potential clinical efficacy of intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal stem cells in the treatment of patients with established chronic spinal cord injury (LEM).

Conditions

Spinal Cord Injury

Keywords

Adult Autologous Bone Marrow Mesenchymal Cells Expanded; chronic spinal cord injury (SCI)

Outcome Measures

Primary Outcomes (1)

• Changes in IANR-SCIFRS score are considerate for the motor and sensory functions evaluation.

  Efficacy evaluation by measuring the change in motor and sensory functions by using the international Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS). This scale includes 9 categories with 16 items in total (plus one optional category). The maximum possible score is 48; the lowest possible score is 0.

  from baseline until the end of the follow up period (24 months)

Secondary Outcomes (5)

• Neurotrophic factors levels in Cerebrospinal fluid (CSF) and/ or Number of Adverse Events related to treatment

  from baseline to 24 months

• Changes in PENN score are considerate for the motor and sensory functions evaluation

  from baseline until the end of the follow up period (24 months)

• Changes in VAS score are considerate for quantification of pain

  from baseline until the end of the follow up period (24 months)

• Changes in BDS score are considerate for the Assessment of the functional status

  from baseline until the end of the follow up period (24 months)

• Changes in GEFFNER score are considerate for the Assessment of the functional status

  from baseline until the end of the follow up period (24 months)

Study Arms (1)

Autologous Mesenchymal Bone Marrow Cell

EXPERIMENTAL

All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow expanded Stem Cell (CME) Pharmaceutical form: Suspension in autologous plasma cell Route of administration: Intrathecal in subarachnoid space by lumbar puncture. Dose: Total dose of 300 x 106 CME, given in 3 injections of 100 x 106 CME, at intervals of 3 months between each administration.

Biological: Autologous Mesenchymal Bone Marrow Cell

Interventions

Autologous Mesenchymal Bone Marrow Cell BIOLOGICAL

Suspension in autologous plasma cell of Adult mesenchymal stem cells expanded autologous bone marrow. Route of administration: Intrathecal in subarachnoid space by lumbar puncture.Total dose of 300 x 106 CME, divided in 3 injections of 100 x 106 CME, with intervals of three months between each administration

Autologous Mesenchymal Bone Marrow Cell

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal cord injury (Level A, B, C or D in ASIA scales), clinically stable for at least 6 months prior to study start.
• Previous studies of Neurophysiology, MRI and Urology to allow useful baseline, in order that they can be compared with the same scans following treatment, and to obtain objective data of potential efficacy.
• Age between 18 and 70 years.
• Men and women of childbearing age must compromise to use contraceptives from the time at which the removal of cells from the bone marrow is performed until 6 months after the Mesenchymal Stem Cells (MSC) last administration by lumbar puncture.
• Possibility of follow up and ability to perform ambulatory physical therapy throughout all treatment period.
• Written informed consent, according to the law in force.
• Hematologic, creatinine, Serum glutamic oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) parameters, within the normal range, according to laboratory standards. However, slight modifications that are considered significant in the context of treatment to be performed, according to the criterion of the research team, are accepted.

You may not qualify if:

• Age below 18 years or above 70.
• Pregnancy or lactation.
• Current neoplastic disease or in the previous 5 years (diagnosed or treated).
• Patients with systemic disease that represents an added risk to treatment.
• Alterations in the genetic study performed to discard risk cell transformation in the expansion process.
• Patients with doubts about possible cooperation in the maintenance physical therapy or in the controls carried out during the study
• Neurodegenerative disease added.
• History of substance abuse, psychiatric disease or allergy to protein products used in the process of cell expansion.
• Positive serology for HIV and syphilis.
• Active Hepatitis B or Hepatitis C, according to serology analysis.
• If in the opinion of the researcher there is some other reason why the patient is not considered candidate for the study.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jesús JV Vaquero Crespo, MD.

  Hospital Universitario Puerta de Hierro-Majadahonda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 7, 2015
• Study Start: July 1, 2015
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting at CTD submission to authorities.
• Access Criteria: Spanish competent authority.

Locations

ES (1)