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

NCT01694927 | Unknown Phase 2

• 1 other identifier: LIT-2012-ACF-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Mesenchymal stem cell; Spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients

  3 months

Secondary Outcomes (3)

• Functional improvement in muscle strength

  1 year

• Functional Improvement in sphincters control

  1 year

• Functional improvement in spasticity control

  1 year

Study Arms (1)

Mesenchymal Stem cells

EXPERIMENTAL

Procedure: Autologous Mesenchymal Stem Cells

Interventions

Autologous Mesenchymal Stem Cells PROCEDURE

Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation

Mesenchymal Stem cells

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute SCI (less than 3 months)
• Active infectious diseases
• Pregnancy
• Neurodegenerative diseases
• Primary hematologic diseases
• Coagulopathies
• Hepatic dysfunction
• Pregnancy

Sponsors & Collaborators

• Clínica Las Condes. LIT INNOVA CORFO: lead

Study Sites (1)

Clínica Las Condes

Santiago, RM, 7591468, Chile

Location

Related Publications (3)

• 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.

  PMID: 19903102 RESULT

• 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.

  PMID: 21303266 RESULT

• 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.

  PMID: 16793729 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Andrés Chahín, MD

  Clínica Las Condes, Santiago

  PRINCIPAL INVESTIGATOR

• Rodrigo M Mardones, MD

  Clínica Las Condes, Santiago

  STUDY DIRECTOR

• Catalina Larrain, MD

  Clínica Las Condes, Santiago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Researcher LIT. Innova CORFO 09IEI6568

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 27, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

CL (1)