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

NCT ID: NCT01694927

Last Updated: 2013-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenchymal Stem cells

Group Type EXPERIMENTAL

Autologous Mesenchymal Stem Cells

Intervention Type PROCEDURE

Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation

Interventions

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Autologous Mesenchymal Stem Cells

Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clínica Las Condes. LIT INNOVA CORFO

OTHER

Sponsor Role lead

Responsible Party

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Clínica Las Condes. LIT INNOVA CORFO

Clinical Researcher LIT. Innova CORFO 09IEI6568

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrés Chahín, MD

Role: PRINCIPAL_INVESTIGATOR

Clínica Las Condes, Santiago

Rodrigo M Mardones, MD

Role: STUDY_DIRECTOR

Clínica Las Condes, Santiago

Catalina Larrain, MD

Role: STUDY_CHAIR

Clínica Las Condes, Santiago

Locations

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Clínica Las Condes

Santiago, RM, Chile

Site Status

Countries

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Chile

References

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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.

Reference Type RESULT
PMID: 19903102 (View on PubMed)

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.

Reference Type RESULT
PMID: 21303266 (View on PubMed)

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.

Reference Type RESULT
PMID: 16793729 (View on PubMed)

Other Identifiers

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LIT-2012-ACF-001

Identifier Type: -

Identifier Source: org_study_id

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