OsteoarthritisPhase 1/2NCT01895413
Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair
A Phase 1/2 study testing Bone marrow aspiration in people with Osteoarthritis, run by Alexandra Cristina Senegaglia at 1 site in Brazil.
Trial summary
This is a non-randomized study aimed to determine the safety and efficacy of intra-articular injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee articular cartilage defects. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Bone marrow aspiration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2012to Jan 2016
- Phase
- Phase 1/2
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with mild to moderate osteoarthritis (visual analogue scale)
- History of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage
Who cannot join
- Any past history of neoplasia and primary hematological disease
- Autoimmune disease or the medical history
- Systemic bone or cartilage disorders
- Acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- Co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy
- Evidence of infection or fractures in or around the joint
- Contraindication to bone marrow aspiration
- Deviation from the axial axis (varus or valgus) greater than 12 degrees.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, 80215-901
About this study
Official title: Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury
This is a non-randomized study aimed to determine the safety and efficacy of intra-articular injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee articular cartilage defects.
Read the detailed description
Osteoarthritis is the most prevalent joint disease, create articular cartilage defects is a frequent cause of joint pain, functional loss, and disability. Osteoarthritis often becomes chronic, and conventional treatments seek to ameliorate pain or improve mobility. However, these treatments rarely modify the course of the disease.Recent studies cell-based have shown encouraging results in both animal studies and a few human case reports. We designed a study to assess the safety and efficacy of osteoarthritis treatment with intra-articular injection of autologous bone marrow-derived mesenchymal stem cells.
- Conditions
- Osteoarthritis
- Being tested
- Bone marrow aspiration
- Keywords
- Cartilage injury, Osteoarthritis, Mesenchymal stem cells
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow aspirationProcedure or surgery
Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells | Experimental | Bone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells Receives: Procedure: Bone marrow aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC (Western Ontario and McMaster Universities)score
Measured: 3 months, 6 months, 9 months, 12 months
Secondary outcomes (3)
Change from baseline in cartilage thickness at 6 months by MRI
Measured: 6 months
Knee pain relief (WOMAC and Lequesne scores)
Measured: 3 months, 6 months, 12 months
Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandra Cristina Senegaglia
- Sponsor type
- University, hospital or other
- Collaborators
- Pontifícia Universidade Católica do Paraná, Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil, Hospital Marcelino Champagnat, Paraná, Brasil, Fundação Araucária
- Responsible party
- Sponsor-investigator, Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná
- Investigators
- Paulo Brofman, PhD, Principal investigator, Pontifícia Universidade Católica do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895413
- Sponsor's protocol ID
- CTM_LESÃO ARTICULAR-461/2010
- Other IDs
- CTM_LESÃO ARTICULAR-461/2010
- Status last verified
- Oct 2015
- First submitted
- 1 Jul 2013
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury
- ClinicalTrials.gov ID
- NCT01895413
- Acronym / sponsor ID
- CTM_LESÃO ARTICULAR-461/2010
- Conditions
- Osteoarthritis
- Keywords
- Cartilage injury, Osteoarthritis, Mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alexandra Cristina SenegagliaUniversity, hospital or other
- Collaborators
- Pontifícia Universidade Católica do Paraná, Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil, Hospital Marcelino Champagnat, Paraná, Brasil, Fundação Araucária
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Jul 2013 (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.
This is a non-randomized study aimed to determine the safety and efficacy of intra-articular injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee articular cartilage defects.
Detailed description
Osteoarthritis is the most prevalent joint disease, create articular cartilage defects is a frequent cause of joint pain, functional loss, and disability. Osteoarthritis often becomes chronic, and conventional treatments seek to ameliorate pain or improve mobility. However, these treatments rarely modify the course of the disease.Recent studies cell-based have shown encouraging results in both animal studies and a few human case reports. We designed a study to assess the safety and efficacy of osteoarthritis treatment with intra-articular injection of autologous bone marrow-derived mesenchymal stem cells.
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: Bone marrow aspirationBone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with mild to moderate osteoarthritis (visual analogue scale)
- History of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage
Key exclusion criteria (8 listed)
- Any past history of neoplasia and primary hematological disease
- Autoimmune disease or the medical history
- Systemic bone or cartilage disorders
- Acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- Co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy
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 |
|---|---|---|
| Bone marrow aspirationSingle intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy | Procedure or surgery | Mesenchymal stem cells |
Primary outcome
Change in WOMAC (Western Ontario and McMaster Universities)score
Time frame: 3 months, 6 months, 9 months, 12 months
3 secondary outcomes
Change from baseline in cartilage thickness at 6 months by MRI
Time frame: 6 months
Knee pain relief (WOMAC and Lequesne scores)
Time frame: 3 months, 6 months, 12 months
Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
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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.
Paulo Brofman, PhD principal investigator
Pontifícia Universidade Católica do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bone marrow aspiration in people with Osteoarthritis, run by Alexandra Cristina Senegaglia at 1 site in Brazil.
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 2 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: finished, as of the sponsor's last update on 13 Dec 2017. 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 Brazil. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in WOMAC (Western Ontario and McMaster Universities)score (time frame: 3 months, 6 months, 9 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2017.