Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients (MSC-SCI)
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ClinicalTrials.gov Identifier: NCT01694927 |
Recruitment Status : Unknown
Verified July 2013 by Clínica Las Condes. LIT INNOVA CORFO, Clinica las Condes, Chile.
Recruitment status was: Enrolling by invitation
First Posted : September 27, 2012
Last Update Posted : July 3, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injury | Procedure: Autologous Mesenchymal Stem Cells | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Mesenchymal Stem cells |
Procedure: Autologous Mesenchymal Stem Cells
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation |
- Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients [ Time Frame: 3 months ]
- Functional improvement in muscle strength [ Time Frame: 1 year ]According to motor index score
- Functional Improvement in sphincters control [ Time Frame: 1 year ]
- Functional improvement in spasticity control [ Time Frame: 1 year ]

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Ages Eligible for Study: | 2 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01694927
Chile | |
Clínica Las Condes | |
Santiago, RM, Chile, 7591468 |
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 |
Responsible Party: | Clínica Las Condes. LIT INNOVA CORFO, Clinical Researcher LIT. Innova CORFO 09IEI6568, Clinica las Condes, Chile |
ClinicalTrials.gov Identifier: | NCT01694927 |
Other Study ID Numbers: |
LIT-2012-ACF-001 |
First Posted: | September 27, 2012 Key Record Dates |
Last Update Posted: | July 3, 2013 |
Last Verified: | July 2013 |
Mesenchymal stem cell Spinal cord injury |
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |