Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia (CME-LEM1)
|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.
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|