Back to resultsAutologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients (MSC-SCI)
Primary Purpose
Spinal Cord Injury
Status
Unknown status
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Autologous Mesenchymal Stem Cells
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Mesenchymal stem cell, Spinal cord injury
Eligibility Criteria
Inclusion Criteria:
- American Spinal Injury Association Impairment (ASIA) Scale A, B and C
- Cervical (under C4), thoracic o lumbar spine lesion
- Complete or Incomplete SCI
- Platelet count over 100.000/ul
Exclusion Criteria:
- Acute SCI (less than 3 months)
- Active infectious diseases
- Pregnancy
- Neurodegenerative diseases
- Primary hematologic diseases
- Coagulopathies
- Hepatic dysfunction
- Pregnancy
Sites / Locations
- Clínica Las Condes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mesenchymal Stem cells
Arm Description
Outcomes
Primary Outcome Measures
Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients
Secondary Outcome Measures
Functional improvement in muscle strength
According to motor index score
Functional Improvement in sphincters control
Functional improvement in spasticity control
Full Information
NCT ID
NCT01694927
First Posted
September 25, 2012
Last Updated
July 2, 2013
Sponsor
Clínica Las Condes. LIT INNOVA CORFO
1. Study Identification
Unique Protocol Identification Number
NCT01694927
Brief Title
Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
Acronym
MSC-SCI
Official Title
Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Clínica Las Condes. LIT INNOVA CORFO
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells intralesional transplantation as a safe and potentially beneficial treatment for patients with spinal cord injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Mesenchymal stem cell, Spinal cord injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal Stem cells
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Autologous Mesenchymal Stem Cells
Intervention Description
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation
Primary Outcome Measure Information:
Title
Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Functional improvement in muscle strength
Description
According to motor index score
Time Frame
1 year
Title
Functional Improvement in sphincters control
Time Frame
1 year
Title
Functional improvement in spasticity control
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Spinal Injury Association Impairment (ASIA) Scale A, B and C
Cervical (under C4), thoracic o lumbar spine lesion
Complete or Incomplete SCI
Platelet count over 100.000/ul
Exclusion Criteria:
Acute SCI (less than 3 months)
Active infectious diseases
Pregnancy
Neurodegenerative diseases
Primary hematologic diseases
Coagulopathies
Hepatic dysfunction
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrés Chahín, MD
Organizational Affiliation
Clínica Las Condes, Santiago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodrigo M Mardones, MD
Organizational Affiliation
Clínica Las Condes, Santiago
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Catalina Larrain, MD
Organizational Affiliation
Clínica Las Condes, Santiago
Official's Role
Study Chair
Facility Information:
Facility Name
Clínica Las Condes
City
Santiago
State/Province
RM
ZIP/Postal Code
7591468
Country
Chile
12. IPD Sharing Statement
Citations:
PubMed Identifier
19903102
Citation
Pal R, Venkataramana NK, Bansal A, Balaraju S, Jan M, Chandra R, Dixit A, Rauthan A, Murgod U, Totey S. Ex vivo-expanded autologous bone marrow-derived mesenchymal stromal cells in human spinal cord injury/paraplegia: a pilot clinical study. Cytotherapy. 2009;11(7):897-911. doi: 10.3109/14653240903253857.
Results Reference
result
PubMed Identifier
21303266
Citation
Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
Results Reference
result
PubMed Identifier
16793729
Citation
Moviglia GA, Fernandez Vina R, Brizuela JA, Saslavsky J, Vrsalovic F, Varela G, Bastos F, Farina P, Etchegaray G, Barbieri M, Martinez G, Picasso F, Schmidt Y, Brizuela P, Gaeta CA, Costanzo H, Moviglia Brandolino MT, Merino S, Pes ME, Veloso MJ, Rugilo C, Tamer I, Shuster GS. Combined protocol of cell therapy for chronic spinal cord injury. Report on the electrical and functional recovery of two patients. Cytotherapy. 2006;8(3):202-9. doi: 10.1080/14653240600736048.
Results Reference
result
Learn more about this trial
Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
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