Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients (MSC-SCI)
July 2, 2013 updated by: Clínica Las Condes. LIT INNOVA CORFO
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RM
-
Santiago, RM, Chile, 7591468
- Clinica Las Condes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mesenchymal Stem cells
|
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional improvement in muscle strength
Time Frame: 1 year
|
According to motor index score
|
1 year
|
|
Functional Improvement in sphincters control
Time Frame: 1 year
|
1 year
|
|
|
Functional improvement in spasticity control
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrés Chahín, MD, Clínica Las Condes, Santiago
- Study Director: Rodrigo M Mardones, MD, Clínica Las Condes, Santiago
- Study Chair: Catalina Larrain, MD, Clínica Las Condes, Santiago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
June 1, 2014
Study Registration Dates
First Submitted
September 25, 2012
First Submitted That Met QC Criteria
September 25, 2012
First Posted (Estimate)
September 27, 2012
Study Record Updates
Last Update Posted (Estimate)
July 3, 2013
Last Update Submitted That Met QC Criteria
July 2, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIT-2012-ACF-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.