Osteoarthritis KneePhase 2/3NCT05783154
Effect of Mesenchymal Stem Cells in Primary Knee Osteoarthritis
A Phase 2/3 study testing Autologous Adipose Tissue-Derived Mesenchymal Stem Cell in people with Osteoarthritis Knee, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Osteoarthritis (OA) is the most prevalent chronic joint disorder worldwide and is associated with significant pain and disability. Incidence and prevalence of osteoarthritis rise with increasing age. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis Knee
- What is being tested?
- Autologous Adipose Tissue-Derived Mesenchymal Stem Cell
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBangladesh
- Study dates
- 16 Sep 2022to 30 Sep 2024
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of the target knee refractory to conventional treatment only.
- Age between 40-70 years.
- All the genders.
- Participant with knee pain who fulfill 2016 revised American College of Rheumatology (ACR) criteria for OA knee
- The Kellgren and Lawrence Grade ≥2 patients.
- Pain score >3 on Visual analog scale [VAS], (0-10 cm scale).
Who cannot join
- Previous diagnosis of poly-articular disease
- Severe mechanical extra-articular deformation (>15° varus/15° valgus)
- Systemic auto-immune rheumatic disease
- Arthroscopy or intra-articular infiltration in the last 6 months
- Chronic treatment with Immunosuppressive or anticoagulant drugs
- Corticosteroids treatment in the 3 last months
Show all 10Show fewer
- Non-steroidal anti-inflammatory drugs therapy in the last 15 days
- Poorly controlled Diabetes mellitus, blood dyscrasias
- Septic or tubercular arthritis
- Recent trauma, fracture, and unstable knee joint
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangabandhu Sheikh Mujib Medical University
Dhaka
Moshiur Rahman Khasru, MBBS, FCPS, +8801716045646, drkhasrupmr@bsmmu.edu.bd
Moshiur Rahman Khasru, MBBS, FCPS
About this study
Official title: Effect of Autologous Adipose Tissue-derived Mesenchymal Stem Cells (AT-MSCs) Therapy in Cartilage Regeneration Among Individuals With Primary Knee Osteoarthritis: A Randomized Clinical Trial
Osteoarthritis (OA) is the most prevalent chronic joint disorder worldwide and is associated with significant pain and disability. Incidence and prevalence of osteoarthritis rise with increasing age. The prevalence of OA knee in Bangladesh seems to be higher due to poor working conditions, heavy physical labor, and occupational injuries which increase in the future. This will ultimately create a higher clinical and socioeconomic burden on the population and national economy. The course of the disease varies but is often progressive. OA of the knee is one of the common self-reported musculoskeletal pain conditions causing patients to visit the Physical Medicine and Rehabilitation (PM\&R) department, at BSMMU. The primary objectives of knee OA treatment focus on pain reduction, and joint mobility improvement, as well as the reduction of disease progression and preserving patients' independence and quality of life. Current treatments aim at alleviating these symptoms by several different methods: Non-pharmacological treatments, Pharmacological treatments, and Invasive interventions. Mesenchymal stem cells (MSCs) therapies for knee osteoarthritis are being investigated in various corners of the world. Both positive and negative findings were observed in that research. Although, the effectiveness of MSCs in KOA is not yet well known. Some studies found MSCs effective, and safe in KOA, and it has the potential to regenerate/heal degraded joint cartilage. MSCs can differentiate into cartilage tissue. Furthermore, MSCs have been shown to have paracrine anti-inflammatory and immunomodulatory effects by producing different growth factors and cytokines. This therapeutics option is under investigation to date. The objective of this trial is to find the effectiveness, safety, and dose difference of adipose tissue-derived stem cells (AT-MSCs) therapy for the treatment of knee osteoarthritis (KOA).
But in fact, there is no published data about the effectiveness of autologous adipose tissue-derived mesenchymal stem cells injection on pain, joint functioning, and femoral cartilage thickness in the management of knee osteoarthritis in Bangladesh. Henceforth, this trial will generate new knowledge about the effectiveness, safety, and appropriate dose of AT-MSCs for KOA. So this research will be helpful to generate evidence-based information for an effective treatment option for the management of KOA.
- Conditions
- Osteoarthritis Knee
- Being tested
- Autologous Adipose Tissue-Derived Mesenchymal Stem Cell
- Keywords
- Osteoarthritis, Pain, Mesenchymal Stem Cell Therapy, Physical function, Outcome, Effectiveness, Disability, Quality of Life
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose Tissue-Derived Mesenchymal Stem CellBiological
After cleaning the knee with 10% povidone-iodine (Povidep10% solution, manufactured by Jayson Pharmaceuticals limited, Bangladesh) and draping it in a sterile manner, the injection site will be anesthetized with 0.5% bupivacaine (Inj. Bupi Heavy 0.5%, Manufactured by Popular Pharmaceuticals limited, Bangladesh) superficially outside of joint capsule.
Within one hour of preparation, the autologous AT-MSC will be injected into each knee joint through medial tibio-femoral compartment in group -I using a 38-mm 18- gauge needle
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Group-1) | No intervention | In control group: 42 patients with primary KOA will receive standard conventional care including rehabilitation for knee osteoarthritis. |
| Experimental Group (Group-2) | Experimental | In the interventional group, another 42 patients with primary KOA will receive adipose tissue-derived mesenchymal stem cells (AT-MSCs) injection intra-articularly (Group-2). However, group-2 (Interventional group) will be subdivided into two sub-groups namely group-2a, and group-2b. A total of 21 Participants of group-2a will receive single doses of autologous adipose tissue-derived stem cell (AT-MSCs) and standard conservative care including rehabilitation for KOA. Whereas, group-2b, 21 respondents will receive two doses of autologous adipose tissue-derived stem cell (AT-MSCs) at 3 months intervals along with standard conservative care including rehabilitation for KOA. Receives: Biological: Autologous Adipose Tissue-Derived Mesenchymal Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Articular Cartilage Defect
Cartilage defect will be evaluated by MRI Osteoarthritis Knee score (MOAKS). MOAKS will be considered to describe the cartilage defect. In MOAKS the knee is divided into 14 articular sub-regions for scoring articular cartilage and Bone Marrow Lesions (BML) [0-100%] where higher score indicates more bone-marrow-lesion and the BML grades are as follows: grade 0= none, grade 1 <33%, grade 2= 33-66% and grade 3 >66%.
Measured: Cartilage defect will be measure before and after treatment at the month 6 and 12.
Changes in Femoral Cartilage thickness
Femoral cartilage thickness will be measured at the three level specifically medial condyle, lateral condyle and intercondylar notch using high frequency ultrasound (Machine Model: Chison Qbit-7, Transducer: 15 mega hertz (MHz) Linear). Mean value of the three measurement will be considered for mean femoral cartilage thickness (0-4 mm).
Measured: Mean femoral cartilage will be measured before and after treatment at the month 6, and12.
Changes in the Pain Intensity
Pain intensity of the knee joint will be evaluated by visual analogue scale (VAS) ranges between 0 to 10 (0-10 cm scale) where score 0 indicate 'no pain' and 10 indicates 'worst pain'.
Measured: Pain intensity will be measured before and after treatment at the month 1, 3, 6, and12
Changes in Physical functioning
Physical functioning will be measured by The Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale. WOMAC has 17 item Physical Function measure where each item score ranges between 0 to 4, and total physical function score ranges between 0-68. The higher score indicates worse physical function of the joint examined.
Measured: Physical functioning will be measured before and after treatment at the month 1, 3, 6, and 12
Secondary outcomes (1)
Any Complications arises
Any immediate and late complications will be documents up to 12 months after the treatment.
All the participants will be examined for any complications during each scheduled follow-up at the month 1, 3, 6, and 12 after treatment.
Moreover, all the participants will be asked to communicate with the investigator team for any complication/issue arises at any time within 12 months of the treatment by dedicated mobile phone number, which will be given to all the participants.
Measured: At the month 1, 3, 6, and 12 after treatment as well as at anytime within 12 months of the treatment (if required)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start16 Sep 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis KneeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshiur Rahman Khasru, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Moshiur Rahman Khasru, MBBS, FCPS, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783154
- Sponsor's protocol ID
- BSMMU/2022/8897
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is yet to decide by the research team
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autologous Adipose Tissue-derived Mesenchymal Stem Cells (AT-MSCs) Therapy in Cartilage Regeneration Among Individuals With Primary Knee Osteoarthritis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05783154
- Acronym / sponsor ID
- BSMMU/2022/8897
- Conditions
- Osteoarthritis Knee
- Keywords
- Osteoarthritis, Pain, Mesenchymal Stem Cell Therapy, Physical function, Outcome, Effectiveness, Disability, Quality of Life
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 24 Mar 2023 (actual)
- 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 (OA) is the most prevalent chronic joint disorder worldwide and is associated with significant pain and disability. Incidence and prevalence of osteoarthritis rise with increasing age. The prevalence of OA knee in Bangladesh seems to be higher due to poor working conditions, heavy physical labor, and occupational injuries which increase in the future. This will ultimately create a higher clinical and socioeconomic burden on the population and national economy. The course of the disease varies but is often progressive. OA of the knee is one of the common self-reported musculoskeletal pain conditions causing patients to visit the Physical Medicine and Rehabilitation (PM\&R) department, at BSMMU. The primary objectives of knee OA treatment focus on pain reduction, and joint mobility improvement, as well as the reduction of disease progression and preserving patients' independence and quality of life. Current treatments aim at alleviating these symptoms by several different methods: Non-pharmacological treatments, Pharmacological treatments, and Invasive interventions. Mesenchymal stem cells (MSCs) therapies for knee osteoarthritis are being investigated in various corners of the world. Both positive and negative findings were observed in that research. Although, the effectiveness of MSCs in KOA is not yet well known. Some studies found MSCs effective, and safe in KOA, and it has the potential to regenerate/heal degraded joint cartilage. MSCs can differentiate into cartilage tissue. Furthermore, MSCs have been shown to have paracrine anti-inflammatory and immunomodulatory effects by producing different growth factors and cytokines. This therapeutics option is under investigation to date. The objective of this trial is to find the effectiveness, safety, and dose difference of adipose tissue-derived stem cells (AT-MSCs) therapy for the treatment of knee osteoarthritis (KOA).
But in fact, there is no published data about the effectiveness of autologous adipose tissue-derived mesenchymal stem cells injection on pain, joint functioning, and femoral cartilage thickness in the management of knee osteoarthritis in Bangladesh. Henceforth, this trial will generate new knowledge about the effectiveness, safety, and appropriate dose of AT-MSCs for KOA. So this research will be helpful to generate evidence-based information for an effective treatment option for the management of KOA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (Group-1) | No intervention | –In control group: 42 patients with primary KOA will receive standard conventional care including rehabilitation for knee osteoarthritis. |
| Experimental Group (Group-2) | Experimental | Biological: Autologous Adipose Tissue-Derived Mesenchymal Stem CellIn the interventional group, another 42 patients with primary KOA will receive adipose tissue-derived mesenchymal stem cells (AT-MSCs) injection intra-articularly (Group-2). However, group-2 (Interventional group) will be subdivided into two sub-groups namely group-2a, and group-2b. A total of 21 Participants of group-2a will receive single doses of autologous adipose tissue-derived stem cell (AT-MSCs) and standard conservative care including rehabilitation for KOA. Whereas, group-2b, 21 respondents will receive two doses of autologous adipose tissue-derived stem cell (AT-MSCs) at 3 months intervals along with standard conservative care including rehabilitation for KOA. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary osteoarthritis of the target knee refractory to conventional treatment only.
- Age between 40-70 years.
- All the genders.
- Participant with knee pain who fulfill 2016 revised American College of Rheumatology (ACR) criteria for OA knee
- The Kellgren and Lawrence Grade ≥2 patients.
Key exclusion criteria (10 listed)
- Previous diagnosis of poly-articular disease
- Severe mechanical extra-articular deformation (>15° varus/15° valgus)
- Systemic auto-immune rheumatic disease
- Arthroscopy or intra-articular infiltration in the last 6 months
- Chronic treatment with Immunosuppressive or anticoagulant drugs
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 Adipose Tissue-Derived Mesenchymal Stem CellAfter cleaning the knee with 10% povidone-iodine (Povidep10% solution, manufactured by Jayson Pharmaceuticals limited, Bangladesh) and draping it in a sterile manner, the injection site will be anesthetized with 0.5% bupivacaine (Inj. Bupi Heavy 0.5%, Manufactured by Popular Pharmaceuticals limited, Bangladesh) superficially outside of joint capsule. Within one hour of preparation, the autologous AT-MSC will be injected into each knee joint through medial tibio-femoral compartment in group -I using a 38-mm 18- gauge needle | Biological | Experimental Group (Group-2) |
Primary outcome
Changes in the Articular Cartilage Defect
Time frame: Cartilage defect will be measure before and after treatment at the month 6 and 12.
Cartilage defect will be evaluated by MRI Osteoarthritis Knee score (MOAKS). MOAKS will be considered to describe the cartilage defect. In MOAKS the knee is divided into 14 articular sub-regions for scoring articular cartilage and Bone Marrow Lesions (BML) [0-100%] where higher score indicates more bone-marrow-lesion and the BML grades are as follows: grade 0= none, grade 1 <33%, grade 2= 33-66% and grade 3 >66%.
Changes in Femoral Cartilage thickness
Time frame: Mean femoral cartilage will be measured before and after treatment at the month 6, and12.
Femoral cartilage thickness will be measured at the three level specifically medial condyle, lateral condyle and intercondylar notch using high frequency ultrasound (Machine Model: Chison Qbit-7, Transducer: 15 mega hertz (MHz) Linear). Mean value of the three measurement will be considered for mean femoral cartilage thickness (0-4 mm).
Changes in the Pain Intensity
Time frame: Pain intensity will be measured before and after treatment at the month 1, 3, 6, and12
Pain intensity of the knee joint will be evaluated by visual analogue scale (VAS) ranges between 0 to 10 (0-10 cm scale) where score 0 indicate 'no pain' and 10 indicates 'worst pain'.
Changes in Physical functioning
Time frame: Physical functioning will be measured before and after treatment at the month 1, 3, 6, and 12
Physical functioning will be measured by The Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale. WOMAC has 17 item Physical Function measure where each item score ranges between 0 to 4, and total physical function score ranges between 0-68. The higher score indicates worse physical function of the joint examined.
1 secondary outcome
Any Complications arises
Time frame: At the month 1, 3, 6, and 12 after treatment as well as at anytime within 12 months of the treatment (if required)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided. It is yet to decide by the research team
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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.
Moshiur Rahman Khasru, MBBS, FCPS principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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 Autologous Adipose Tissue-Derived Mesenchymal Stem Cell in people with Osteoarthritis Knee, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 6 inclusion and 10 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 24 Mar 2023. 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 Bangladesh. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moshiur Rahman Khasru, MBBS, FCPS (+8801716045646, drkhasrupmr@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Articular Cartilage Defect (time frame: Cartilage defect will be measure before and after treatment at the month 6 and 12.). The study lists 4 primary outcomes in all. 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 24 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.