Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients

Spinal Cord Injury Clinical Trial

— MSC-SCI  

Official title:

Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01694927
• Other study ID #: LIT-2012-ACF-001
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: September 25, 2012
• Last updated: July 2, 2013
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2013
• Source: Clinica las Condes, Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Procedure:
• Autologous Mesenchymal Stem Cells
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation

Locations

Country	Name	City	State
Chile	Clínica Las Condes	Santiago	RM

Sponsors (1)

Lead Sponsor	Collaborator
Clínica Las Condes. LIT INNOVA CORFO

Country where clinical trial is conducted

Chile, 

References & Publications (3)

Moviglia GA, Fernandez Viña 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 — View 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. — View 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/s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients		3 months	Yes
Secondary	Functional improvement in muscle strength	According to motor index score	1 year	No
Secondary	Functional Improvement in sphincters control		1 year	No
Secondary	Functional improvement in spasticity control		1 year	No