Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia (CME-LEM1)
The objective of the study is confirm the security, and detecting effect of the local administration in damaged nervous tissue, of autologous bone marrow stromal cells. After one year of evolution after starting the treatment, it is possible to have efficacy data of this treatment, either in some kind of improvement in their paralysis or some kind of aspects such as sphincter control, improvement of spasms, pain or any other symptoms you may have as a result of spinal cord injury. However the principal objective of this study is to ensure that the treatment is applied is well tolerated and without complications, as experience with the techniques of cell therapy in humans is currently very limited and specific treatment protocol that will be applied, has not yet been tested in patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Appearance of adverse effects [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
The principal variable will be the appearance of adverse effects during administration and during the follow up period:
On a daily Bases: The first week after first administration of CME. Weekly: Until the second administration of CME After second administration of CME it will be done a weekly clinical assessment and during months 9 and 12 of the follow-up period.
- Sensitivity recovery [ Time Frame: sensitivity recovery during Follow-up period: 3, 6, 9 and 12 months and the baseline visit. ] [ Designated as safety issue: No ]
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.
- Motor recovery [ Time Frame: Motor recovery during administration and during the follow up period: Follow-up period: 3,6,9, and 12 months and baseline visit. ] [ Designated as safety issue: No ]
Motor recovery, changes in the level of chronic pain, neurophysiological parameters improvement, and changes in the spinal cord morphology on neuroimaging studies.
Motor recovery: Follow-up period: 3,6,9, and 12 months and baseline visit.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Depending on centromedullary post-traumatically injury (minimum dose of100x106 CME on a first intermedular and subarachnoid administration and then subarachnoid administration of 30x106CME,3 months later)
Depending on centromedullary , post traumatically injury (minimum dose 100x106 CME on first intermedular and subarachnoid administration,and then subarachnoid administration of 30x106 CME, 3 months later)
Other Name: Autologous cells from the bone marrow stroma
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) stablished who were administered autologous stromal cells of the bone marrow. Expanded cells will be administrated locally intrathecal (subarachnoid and intramedullary) by microinjection and three months later, by lumbar subarachnoid administration. The minimum follow-up time for each patient is 12 months after the first administration, or until death, if it occurs it before.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01909154
|Contact: Jesús JV Vaquero crespo, Neurosurgeon||+34 firstname.lastname@example.org|
|Contact: Mercedes MZ Zurita Castillo, Biologist||+34 email@example.com|
|Hospital Puerta de Hierro||Recruiting|
|Majadahonda, Madrid, Spain, 28222|
|Contact: Jesús JV Vaquero Crespo, Neurosurgeon +34 911916000 firstname.lastname@example.org|
|Contact: Mercedes MZ Zurita Castillo, Biologist +34 911916000 email@example.com|
|Principal Investigator:||Jesus JV Vaquero Crespo, Dr.||Hospital Universitario Puerta de Hierro-Majadahonda|