Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

NCT02165904 | Completed Phase 1 Results

• 2 other identifiers: CME-LEM22011-005684-24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury

Keywords

Analyze clinical efficacy of subarachnoid administration of; autologous BMSC expanded "in vitro"

Outcome Measures

Primary Outcomes (14)

• Efficacy-Sensivity Improvement Using the ASIA Score

  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

  \- 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

  \- 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

  -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.

  \- 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

  \- 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

  • 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

  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

  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)

  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

  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

  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

  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)

  Number of patients with changes in morphology of injury compared with basal images

  before (baseline visit) and at 12 months

Secondary Outcomes (2)

• Number of Adverse Events .

  Up to 12 months

• Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples

  Basal and 10 months after the administration

Study Arms (1)

Autologous Mesenchymal Bone Marrow Cell

EXPERIMENTAL

All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow Cell

Biological: Adult Autologous Mesenchymal Bone Marrow Cell

Interventions

Adult Autologous Mesenchymal Bone Marrow Cell BIOLOGICAL

Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells.

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:

• Incomplete SCI
• Neurological deficit clinically stable at least 12 months prior to treatment, and with a minimum of one-year evolution after SCI.
• Neurophysiological confirmation of incomplete SCI.
• The MRI study that morphologically evaluate the SCI.
• Age between 18 and 70 years
• Thread Men and women will compromise to use anticonceptive issues from first cell´s extraction to 6 months after last cell´s administration.
• Ability to attend clinical follow-up and perform physical therapy through the treatment period.
• Written and signed informed consent, according to the local regulation.
• 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.

You may not qualify if:

• A classification in ASIA and FRANKEL clinical scales to evaluate the SCI.
• Neurophysiological records that confirm the complete SCI.
• Age below 18 years or above 70.
• Pregnancy or lactation.
• Malignancy disease diagnosed or treated within the last 5 years.
• Patients with systemic disease that represents and additional risk to treatment.
• 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.
• Inability to assess the SCI features through MRI either noise due to spinal stabilization systems or any other cause.
• Patients currently under hematopoietic growth factors treatment or who required or maintained anticoagulation.
• Neurodegenerative disease additional.
• History of substance abuse, psychiatric disease or allergy to the protein products used in the process of cell expansion.
• Positive serology for HIV and syphilis.
• Active Hepatitis B or Hepatitis C.
• With other reason that would consider the patient ineligible for cell therapy according to the investigators judgment.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (2)

• Vaquero J, Zurita M. Functional recovery after severe CNS trauma: current perspectives for cell therapy with bone marrow stromal cells. Prog Neurobiol. 2011 Mar;93(3):341-9. doi: 10.1016/j.pneurobio.2010.12.002. Epub 2010 Dec 14.

  PMID: 21163325 BACKGROUND

• Otero L, Zurita M, Bonilla C, Aguayo C, Vela A, Rico MA, Vaquero J. Late transplantation of allogeneic bone marrow stromal cells improves neurologic deficits subsequent to intracerebral hemorrhage. Cytotherapy. 2011 May;13(5):562-71. doi: 10.3109/14653249.2010.544720. Epub 2011 Jan 5.

  PMID: 21208021 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

• Jesús JV Vaquero Crespo, M.D.

  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: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: June 18, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)