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Status unknownNCT01694927MSC-SCIUpdated Jul 3, 2013

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

A Phase 2 interventional study of Autologous Mesenchymal Stem Cells in Spinal Cord Injury, sponsored by Clínica Las Condes. LIT INNOVA CORFO. Status unknown at 1 site in Chile. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-07-03.

Sponsored by Clínica Las Condes. LIT INNOVA CORFO · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
2 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Spinal Cord Injury

Keywords

  • Mesenchymal stem cell
  • Spinal cord injury
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 30 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

This is the only study on the registry with Clínica Las Condes. LIT INNOVA CORFO as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  • Acute SCI (less than 3 months)
  • Active infectious diseases
  • Pregnancy
  • Neurodegenerative diseases
  • Primary hematologic diseases
  • Coagulopathies
  • Hepatic dysfunction
  • Pregnancy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Mesenchymal Stem cells

    Procedure: Autologous Mesenchymal Stem Cells

Interventions

  • ProcedureAutologous Mesenchymal Stem Cells

    Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation

06

What researchers measure

Primary outcomes

  1. Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients

    Time frame: 3 months

Secondary outcomes

  1. Functional improvement in muscle strength

    According to motor index score

    Time frame: 1 year

  2. Functional Improvement in sphincters control

    Time frame: 1 year

  3. Functional improvement in spasticity control

    Time frame: 1 year

07

Study locations

1 site
  • Clínica Las Condes
    Santiago, RM 7591468, Chile
08

References and documents

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. PubMed 19903102 ↗
  • 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. PubMed 21303266 ↗
  • 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. PubMed 16793729 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01694927
Lead sponsor
Clínica Las Condes. LIT INNOVA CORFO
Responsible party
Clínica Las Condes. LIT INNOVA CORFO (Clinical Researcher LIT. Innova CORFO 09IEI6568, Clinica las Condes, Chile) — Sponsor-investigator
First posted
Sep 27, 2012
Start date
Jan 2012
Primary completion
Dec 2013 (estimated)
Completion
Jun 2014 (estimated)
Last update
Jul 3, 2013

Study contacts

Andrés Chahín, MD
principal investigator · Clínica Las Condes, Santiago
Rodrigo M Mardones, MD
study director · Clínica Las Condes, Santiago
Catalina Larrain, MD
study chair · Clínica Las Condes, Santiago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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