Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI

NCT ID: NCT02165904

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-05-31

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.

Detailed 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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous Mesenchymal Bone Marrow Cell

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

Group Type: EXPERIMENTAL

Adult Autologous Mesenchymal Bone Marrow Cell

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Puerta de Hierro University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jesús Vaquero Crespo, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesús JV Vaquero Crespo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Puerta de Hierro-Majadahonda

Locations

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 21163325 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21208021 (View on PubMed)

Other Identifiers

2011-005684-24

Identifier Type: REGISTRY

Identifier Source: secondary_id

CME-LEM2

Identifier Type: -

Identifier Source: org_study_id