Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02165904
Other study ID # CME-LEM2
Secondary ID 2011-005684-24
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2014
Est. completion date May 2016

Study information

Verified date May 2019
Source Puerta de Hierro University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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.

Locations

Country Name City State
Spain Hospital Puerta de Hierro Majadahonda Madrid

Sponsors (1)

Lead Sponsor Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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)
Primary 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
Primary 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
Primary 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
Primary 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)
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Number of Adverse Events . - 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
Secondary Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples 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
See also
  Status Clinical Trial Phase
Recruiting NCT02574572 - Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury Phase 1
Recruiting NCT05941819 - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury N/A
Completed NCT05265377 - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury N/A
Recruiting NCT02331979 - Improving Bladder Function in SCI by Neuromodulation N/A
Completed NCT02777281 - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI N/A
Recruiting NCT02978638 - Electrical Stimulation for Continence After Spinal Cord Injury N/A
Completed NCT02262234 - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study Phase 1/Phase 2
Withdrawn NCT02237547 - Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury Phase 1/Phase 2
Completed NCT02161913 - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers N/A
Terminated NCT02080039 - Electrical Stimulation of Denervated Muscles After Spinal Cord Injury N/A
Completed NCT01642901 - Zoledronic Acid in Acute Spinal Cord Injury Phase 3
Completed NCT01884662 - Virtual Walking for Neuropathic Pain in Spinal Cord Injury N/A
Completed NCT01471613 - Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury Phase 1/Phase 2
Terminated NCT01433159 - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury Phase 2
Completed NCT02149511 - Longitudinal Morphometric Changes Following SCI
Completed NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
Terminated NCT01005615 - Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury Phase 1/Phase 2
Completed NCT01025609 - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Completed NCT01086930 - Early Intensive Hand Rehabilitation After Spinal Cord Injury Phase 3