Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

Puerta de Hierro University Hospital10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Adult Autologous Mesenchymal Bone Marrow CellBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery

Data from ClinicalTrials.gov

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Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes