Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia (CME-LEM1)
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|ClinicalTrials.gov Identifier: NCT01909154|
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : June 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Biological: Mesenchymal stromal cell therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Pilot Study to Evaluate the Security of Local Administration of Autologous Stem Cells Obtained From the Bone Marrow Stroma, in Traumatic Injuries of the Spinal Cord|
|Study Start Date :||March 2013|
|Primary Completion Date :||April 2014|
|Study Completion Date :||March 2015|
Experimental: Mesenchymal stromal cell therapy
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
Other Name: BMMSCs= Bone Marrow Mesenchymal Stem Cells
- Safety [ Time Frame: Up to 12 months ]
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.
- Efficacy [ Time Frame: sensitivity recovery during Follow-up period: 3, 6, 9 and 12 months and the baseline visit. ]
Sensitivity recovery, changes in the level of chronic pain, neurophysiological parameters improvement, and changes in the spinal cord morphology on neuroimaging studies.
Sensitive recovery: Follow-up period: 3, 6, 9 and 12 months and the baseline visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909154
|Hospital Puerta de Hierro|
|Majadahonda, Madrid, Spain, 28222|
|Principal Investigator:||Jesus JV Vaquero Crespo, Dr.||Hospital Universitario Puerta de Hierro-Majadahonda|