OsteoarthritisPhase 2NCT01459640
Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis
A Phase 2 study testing Hyaluronic Acid and Autologous bone marrow-derived mesenchymal stem cells in people with Osteoarthritis, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Osteoarthritis is a progressively degenerative disease resulting in increasing pain, impairment and ultimately disability. While the available treatments seek to ameliorate pain or improve mobility, these treatments rarely modify the course of the disease, but rather attend to its consequences. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hyaluronic Acid and Autologous bone marrow-derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- Mar 2011to Mar 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with mild to moderate osteoarthritis based on Kellgren-Lawrence radiographic classification
- Has a history of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage
Who cannot join
- Has systemic bone or cartilage disorders
- Has significant vascular impairment proximal to implant site
- Has substantial joint destabilization including extensive osteophyte formation
- Has substantial surface erosion of the weight-bearing articular cartilage
- Evidence of infection or fractures in or around the joint
- Contraindication to bone marrow aspiration
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- Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- Any past history of neoplasia and primary hematological disease
- Renal impairment indicated by serum creatinine greater than 200mM
- Liver impairment indicated by serum aspartate transaminase and serum alanine transaminase greater than 120 IU
- Any other co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy
Trial locations and contacts
1 site in 1 country.
Ya Mohammad Hassan Shukur, MD contact
Malaysia1 site, 1 recruiting
- Recruiting
UKM Medical Centre
Kuala Lumpur, 56000
Ya Mohammad Hassan Shukur, MD
Ya Mohammad Hassan Shukur, MD
About this study
Official title: Phase 2 Study Assessing the Efficacy of Intra-Articular Autologous Mesenchymal Stem Cells in Patients With Mild to Moderate Osteoarthritis
Osteoarthritis is a progressively degenerative disease resulting in increasing pain, impairment and ultimately disability. While the available treatments seek to ameliorate pain or improve mobility, these treatments rarely modify the course of the disease, but rather attend to its consequences. For early stage osteoarthritis, treatment is largely limited to addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs). These drugs do not stop the progression of the condition or regenerates damaged cartilage.
This is a randomized and open labelled study aimed to determine the efficacy of intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in patients with mild to moderate osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- Hyaluronic Acid, Autologous bone marrow-derived mesenchymal stem cells
- Keywords
- Osteoarthritis, Bone marrow, Mesenchymal stem cells, Autologous, Mild osteoarthritis, Moderate osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDrug
Also called Orthovisc
Intra-articular injection; 30mg/2ml; three-weekly injection regimen
Autologous bone marrow-derived mesenchymal stem cellsBiological
Single intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in hyaluronic acid "Orthovisc" (3rd injection in a three-weekly injection regimen)
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Active comparator | Not described Receives: Drug: Hyaluronic Acid |
| Bone marrow mesenchymal stem cells | Experimental | Autologous bone marrow-derived mesenchymal stem cells Receives: Biological: Autologous bone marrow-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cartilage thickness at 12 months by MRI
Measured: 12 months
Secondary outcomes (3)
Visual Analog Score
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
IKDC Subjective Knee Evaluation Form (2000)
Measured: 1 month, 3 months, 6 months, 9 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 posted25 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Cytopeutics Pte. Ltd.
- Responsible party
- Principal investigator, Dr Ya Mohammad Hassan Shukur, National University of Malaysia
- Investigators
- Ya Mohammad Hassan Shukur, MD, Principal investigator, UKM Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459640
- Sponsor's protocol ID
- FF-114-2011
- Status last verified
- Oct 2011
- First submitted
- 24 Oct 2011
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Assessing the Efficacy of Intra-Articular Autologous Mesenchymal Stem Cells in Patients With Mild to Moderate Osteoarthritis
- ClinicalTrials.gov ID
- NCT01459640
- Acronym / sponsor ID
- FF-114-2011
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Bone marrow, Mesenchymal stem cells, Autologous, Mild osteoarthritis, Moderate osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Cytopeutics Pte. Ltd.
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 25 Oct 2011 (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.
Osteoarthritis is a progressively degenerative disease resulting in increasing pain, impairment and ultimately disability. While the available treatments seek to ameliorate pain or improve mobility, these treatments rarely modify the course of the disease, but rather attend to its consequences. For early stage osteoarthritis, treatment is largely limited to addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs). These drugs do not stop the progression of the condition or regenerates damaged cartilage.
This is a randomized and open labelled study aimed to determine the efficacy of intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in patients with mild to moderate osteoarthritis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Active comparator | Drug: Hyaluronic Acid |
| Bone marrow mesenchymal stem cells | Experimental | Biological: Autologous bone marrow-derived mesenchymal stem cellsAutologous bone marrow-derived mesenchymal stem cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with mild to moderate osteoarthritis based on Kellgren-Lawrence radiographic classification
- Has a history of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage
Key exclusion criteria (11 listed)
- Has systemic bone or cartilage disorders
- Has significant vascular impairment proximal to implant site
- Has substantial joint destabilization including extensive osteophyte formation
- Has substantial surface erosion of the weight-bearing articular cartilage
- Evidence of infection or fractures in or around the joint
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 |
|---|---|---|
| Hyaluronic AcidAlso: OrthoviscIntra-articular injection; 30mg/2ml; three-weekly injection regimen | Drug | Hyaluronic acid |
| Autologous bone marrow-derived mesenchymal stem cellsSingle intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in hyaluronic acid "Orthovisc" (3rd injection in a three-weekly injection regimen) | Biological | Bone marrow mesenchymal stem cells |
Primary outcome
Change from baseline in cartilage thickness at 12 months by MRI
Time frame: 12 months
3 secondary outcomes
Visual Analog Score
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
IKDC Subjective Knee Evaluation Form (2000)
Time frame: 1 month, 3 months, 6 months, 9 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Ya Mohammad Hassan Shukur, MD contact
Ya Mohammad Hassan Shukur, MD principal investigator
UKM Medical Centre
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 Hyaluronic Acid and Autologous bone marrow-derived mesenchymal stem cells in people with Osteoarthritis, run by National University of Malaysia at 1 site in Malaysia.
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 11 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 25 Oct 2011. 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 Malaysia. 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?
Contact Ya Mohammad Hassan Shukur, MD (mhassan@ppukm.ukm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in cartilage thickness at 12 months by MRI (time frame: 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 25 Oct 2011.