Spinal Cord InjuryPhase 2MSC-SCINCT01694927
Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
A Phase 2 study testing Autologous Mesenchymal Stem Cells in people with Spinal Cord Injury, run by Clínica Las Condes. LIT INNOVA CORFO at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Autologous Mesenchymal Stem Cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- Jan 2012to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute SCI (less than 3 months)
- Active infectious diseases
- Pregnancy
- Neurodegenerative diseases
- Primary hematologic diseases
- Coagulopathies
- Hepatic dysfunction
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Autologous Mesenchymal Stem Cells
- Keywords
- Mesenchymal stem cell, Spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Mesenchymal Stem CellsProcedure or surgery
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stem cells | Experimental | Not described Receives: Procedure: Autologous Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients
Measured: 3 months
Secondary outcomes (3)
Functional improvement in muscle strength
According to motor index score
Measured: 1 year
Functional Improvement in sphincters control
Measured: 1 year
Functional improvement in spasticity control
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clínica Las Condes. LIT INNOVA CORFO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clínica Las Condes. LIT INNOVA CORFO, Clinica las Condes, Chile
- Investigators
- Andrés Chahín, MD, Principal investigator, Clínica Las Condes, SantiagoRodrigo M Mardones, MD, Study director, Clínica Las Condes, SantiagoCatalina Larrain, MD, Study chair, Clínica Las Condes, Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694927
- Sponsor's protocol ID
- LIT-2012-ACF-001
- Acronym
- MSC-SCI
- Status last verified
- Jul 2013
- First submitted
- 25 Sep 2012
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
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 19903102Ra 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 21303266Moviglia 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
- ClinicalTrials.gov ID
- NCT01694927
- Acronym / sponsor ID
- MSC-SCI / LIT-2012-ACF-001
- Conditions
- Spinal Cord Injury
- Keywords
- Mesenchymal stem cell, Spinal cord injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Clínica Las Condes. LIT INNOVA CORFOUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stem cells | Experimental | Procedure: Autologous Mesenchymal Stem Cells |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Acute SCI (less than 3 months)
- Active infectious diseases
- Pregnancy
- Neurodegenerative diseases
- Primary hematologic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Mesenchymal Stem CellsExpanded Intralesional Autologous Mesenchymal Stem Cells Transplantation | Procedure or surgery | Mesenchymal Stem cells |
Primary outcome
Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients
Time frame: 3 months
3 secondary outcomes
Functional improvement in muscle strength
Time frame: 1 year
Functional Improvement in sphincters control
Time frame: 1 year
Functional improvement in spasticity control
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Results publication: PubMed 19903102Pal 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.
- Results publication: PubMed 21303266Ra 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.
- Results publication: PubMed 16793729Moviglia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Mesenchymal Stem Cells in people with Spinal Cord Injury, run by Clínica Las Condes. LIT INNOVA CORFO at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01694927, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.