Rheumatoid ArthritisPhase 2/3NCT01873625
Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis
A Phase 2/3 study testing mesenchymal cell transplantation in people with Rheumatoid Arthritis, run by Royan Institute at 1 site in Iran.
Trial summary
Osteoarthritis of the knee is one of the most common causes of disability among elderly. Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- mesenchymal cell transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 2/3
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Body mass index (BMI) ≤30 kg/m2
- The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before invitation
Who cannot join
- 1. Response to routine treatment at last one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resurfacing Articular Cartilage With Mesenchymal Stem Cells Transplantation in Patients With Knee Joint Osteoarthritis Affected by Rheumatoid Arthritis: Randomized Triple Blind Clinical Trial Phase II/III (ACRCT)
Osteoarthritis of the knee is one of the most common causes of disability among elderly. Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as knee osteoarthritis. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in 60 patients with knee osteoarthritis.
Read the detailed description
In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A (control group) received only routine medical therapies and placebo injected into there knees.. Group B received mesenchymal stem cells in addition of routine medical therapy.
Patients were categorized according to the following stimulation protocols:
To assess the outcomes, after mesenchymal stem cells transplantation at months 1,3,6 and 12 we will examine the patients by: WOMAC questioners, DAS28 scoring , radiographies assessments and biochemical analysis with laboratory tests.
- Conditions
- Rheumatoid Arthritis
- Being tested
- mesenchymal cell transplantation, placebo
- Keywords
- mesenchymal stem cells, osteoarthritis, arthritis rheumatoid
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal cell transplantationBiological
Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
placeboBiological
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Normal salin injection in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis. Receives: Biological: placebo |
| mesencymal stem cell | Active comparator | Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis. Receives: Biological: mesenchymal cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Evaluation the pain reduction after mesenchymal stem cell transplantation that measured by VAS scaling.
Measured: 1month
physical activity
evaluation the improvement of physical activity after mesenchymal stem cell transplantation that measured by WOMAC scoring.
Measured: 1month
walking distance
Evaluation the walking distance after mesenchymal transplantation.
Measured: 1month
Secondary outcomes (1)
Imaging
Evaluation the resurfacing of articular cartilage after mesenchymal transplantation by MRI and radio logic assessment.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of regenerative medicine department, head of Royan cell therapy centerMohsen Emadedin, MD, Study director, Royan Institute,Department of regenerative medicineFarhad gharibdoost, MD, Study director, President of rheumatologic association center of IranSoraya Shadmanfar, MD, Principal investigator, Royan Institute, Department of regenerative medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873625
- Sponsor's protocol ID
- Royan-RA-001
- Status last verified
- Aug 2009
- First submitted
- 5 Jun 2013
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shadmanfar S, Labibzadeh N, Emadedin M, Jaroughi N, Azimian V, Mardpour S, Kakroodi FA, Bolurieh T, Hosseini SE, Chehrazi M, Niknejadi M, Baharvand H, Gharibdoost F, Aghdami N. Intra-articular knee implantation of autologous bone marrow-derived mesenchymal stromal cells in rheumatoid arthritis patients with knee involvement: Results of a randomized, triple-blind, placebo-controlled phase 1/2 clinical trial. Cytotherapy. 2018 Apr;20(4):499-506. doi: 10.1016/j.jcyt.2017.12.009. Epub 2018 Feb 7.
PubMed 29428486
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resurfacing Articular Cartilage With Mesenchymal Stem Cells Transplantation in Patients With Knee Joint Osteoarthritis Affected by Rheumatoid Arthritis: Randomized Triple Blind Clinical Trial Phase II/III (ACRCT)
- ClinicalTrials.gov ID
- NCT01873625
- Acronym / sponsor ID
- Royan-RA-001
- Conditions
- Rheumatoid Arthritis
- Keywords
- mesenchymal stem cells, osteoarthritis, arthritis rheumatoid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Jun 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.
Osteoarthritis of the knee is one of the most common causes of disability among elderly. Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as knee osteoarthritis. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in 60 patients with knee osteoarthritis.
Detailed description
In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A (control group) received only routine medical therapies and placebo injected into there knees.. Group B received mesenchymal stem cells in addition of routine medical therapy.
Patients were categorized according to the following stimulation protocols:
To assess the outcomes, after mesenchymal stem cells transplantation at months 1,3,6 and 12 we will examine the patients by: WOMAC questioners, DAS28 scoring , radiographies assessments and biochemical analysis with laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Biological: placeboNormal salin injection in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis. |
| mesencymal stem cell | Active comparator | Biological: mesenchymal cell transplantationMesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 65 years
- Body mass index (BMI) ≤30 kg/m2
- The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before invitation
Key exclusion criteria (1 listed)
- 1. Response to routine treatment at last one year.
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 |
|---|---|---|
| mesenchymal cell transplantationMesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis. | Biological | mesencymal stem cell |
| placebo | Biological | placebo |
Primary outcome
pain
Time frame: 1month
Evaluation the pain reduction after mesenchymal stem cell transplantation that measured by VAS scaling.
physical activity
Time frame: 1month
evaluation the improvement of physical activity after mesenchymal stem cell transplantation that measured by WOMAC scoring.
walking distance
Time frame: 1month
Evaluation the walking distance after mesenchymal transplantation.
1 secondary outcome
Imaging
Time frame: 6months
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 10 Jun 2013.
- Derived from this study: PubMed 29428486Shadmanfar S, Labibzadeh N, Emadedin M, Jaroughi N, Azimian V, Mardpour S, Kakroodi FA, Bolurieh T, Hosseini SE, Chehrazi M, Niknejadi M, Baharvand H, Gharibdoost F, Aghdami N. Intra-articular knee implantation of autologous bone marrow-derived mesenchymal stromal cells in rheumatoid arthritis patients with knee involvement: Results of a randomized, triple-blind, placebo-controlled phase 1/2 clinical trial. Cytotherapy. 2018 Apr;20(4):499-506. doi: 10.1016/j.jcyt.2017.12.009. Epub 2018 Feb 7.
- Related InfoLink provided by the sponsor.
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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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of regenerative medicine department, head of Royan cell therapy center
Mohsen Emadedin, MD study director
Royan Institute,Department of regenerative medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing mesenchymal cell transplantation in people with Rheumatoid Arthritis, run by Royan Institute at 1 site in Iran.
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 3 inclusion and 1 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 10 Jun 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 Iran. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
pain (time frame: 1month). The study lists 3 primary outcomes in all. 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 NCT01873625, which also lists 1 linked publication.
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 10 Jun 2013.