Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia

NCT01909154 | Completed Phase 1 Results

• 2 other identifiers: CME-LEM12010-023285-46
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to confirm the security, and detect the effect of the local administration in damaged nervous tissue, of autologous bone marrow stromal cells.

Conditions

Spinal Cord Injury

Keywords

neurophysiological parameters improvement; spinal cord injury; biology therapy

Outcome Measures

Primary Outcomes (1)

• Safety-Number of Adverse Events

  Clinical evaluation of possible adverse effects is performed daily at the first week after the first administration of stem cells and weekly until the 6 months follow-up visit and then at month 9 and 12. . * During the first stem cells administration (during surgery): Changes in vital signs (ECG, Blood Pressure (BP), Heart Rate (HR) were evaluated * During the second stem cells administration: Changes in vital signs (BP, HR), headache and meningeal irritation were evaluated * During the first weeks, after the first and the second administrations, the possibility of meningeal irritation, headache and infectious complications were considerate. MedDRA stardards are followed

  Up to 12 months

Secondary Outcomes (5)

• Efficacy-Sensitivity Recovery Using ASIA Scale

  sensitivity before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)

• Efficacy-Changes in the Level of Chronic Pain Based on the IANR-SCIFRS Scale (Pain Section)

  Changes in the level of Chronic pain before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)

• Efficacy- Changes in the Neurophysiological Parameters Measured as the Number of Patients With SSEPs (Somatosensory Evoked Potentials)

  Changes in the level neurophysiological parameters improvement (baseline visit) and 6, 12 months after surgery (follow-up period)

• Efficacy-Urodynamic Studies in Terms of máximum Cystometric Capacity

  Urodynamic studies before surgery and 12 months after surgery (follow-up period)

• Efficacy-modification of Magnetic Resonance Imaging (MRI)

  changes in the spinal cord morphology on neuroimaging studies before surgery and 12 months after surgery (follow-up period)

Study Arms (1)

Mesenchymal stromal cell therapy

EXPERIMENTAL

Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later

Biological: Mesenchymal stromal cell therapy

Interventions

Mesenchymal stromal cell therapy BIOLOGICAL

Stem cells administration locally

Also known as: BMMSCs= Bone Marrow Mesenchymal Stem Cells

Mesenchymal stromal cell therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female with ages between 18 years and 60 years with of age or older functional sequelae chronically established by traumatic injury of the spinal cord (spinal segments between the vertebral bodies C6 and L1) and considered irreversible (not respond to any other treatment). In this study, the lesion is considered chronically established, when there are no signs of functional recovery after a minimum follow-up period of 6 months after the spinal cord injury. The upper age limit is justified by the low potential of in vitro expansion of bone marrow stromal cells over 60 years.
• Complete paraplegia, with loss of motor and sensory function below the lesion (grade A in the American Spinal Injury Association Impairment (ASIA) Scale .
• Spinal injury MRI morphologically visible, and without images that suggest spinal cord transection, with separation of the both ends of the spinal cord.
• Tracking evolutionary possibility after treatment protocol and to comply physiotherapy maintained throughout the follow up period.
• Written informed Consent according to good clinical practice (GCP) and local regulations, obtained before any study procedure.
• Hematological parameters and creatinine, serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) in normal range according to laboratory standards, are accepted, however, small non-significant deviations according to the investigator.

You may not qualify if:

• Pregnancy and lactation
• Systemic disease represents an added risk to treatment
• Patients with questions about their possible cooperation in rehabilitation-physiotherapy treatments later, or negative report psychological assessment prior.
• Neuroimaging data showing spinal cord section with separation of the terminal portion of the spinal cord
• Current neoplastic disease diagnosed or treated in the previous five years
• Patients treated with hematopoietic growth factors or requiring stable anticoagulation
• Added neurodegenerative disease
• History of substance abuse, psychiatric illness or allergy to protein products used in the process of cell expansion
• HIV positive serology and syphilis
• Hepatitis B or Hepatitis C active According to the investigator's opinion if there are findings on physical examination, abnormal clinical test results or other medica relevant entries, social or psychosocial factors which might influence negatively the study.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (1)

• Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. doi: 10.3727/096368908787648074.

  PMID: 19364066 BACKGROUND

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

Results Point of Contact

• Title: Dr. Vaquero Crespo
• Organization: Hospital Universitario Puerta de Hierro Majadahonda, Madrid

jesus.vaquero@salud.madrid.org

91 191 7760

Study Officials

• Jesus JV Vaquero Crespo, Dr.

  Hospital Universitario Puerta de Hierro-Majadahonda

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor on neurosurgery

Study Record Dates

• First Submitted: July 7, 2013
• First Posted: July 26, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 29, 2019
• Results First Posted: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)