Osteoarthritis KneesPhase 2NCT05280002
Adipose-tissue-derived Total-Stromal-cells (TOST) Therapy in Knee Osteoarthritis
A Phase 2 study testing Adipose Tissue derived Total-Stromal-Cells (TOST) in people with Osteoarthritis Knees, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
In this phase II Randomized Clinical Trial (RCT), impacts of a single Intra-articular injection of autologous adipose tissue derive total-stromal-cells (TOST) on knee pain, physical function, stiffness, and cartilage thickness assessed and compared changes before and after intervention. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis Knees
- What is being tested?
- Adipose Tissue derived Total-Stromal-Cells (TOST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jan 2018to 31 Dec 2021
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary KOA with KL-grade II and III radiological changes
Who cannot join
- KOA received IA steroid, viscosupplementation, or PRP injection or undergone knee surgery within the last six months.
- Patients with septic and tubercular arthritis, post-traumatic hemarthrosis, unstable knee joint due to anterior cruciate ligament (ACL) injury, malignancy, autoinflammatory arthritis (gout), inflammatory disease (rheumatoid arthritis, psoriatic arthritis, reactive, and ankylosing spondylitis), and charcot arthropathy.
- Patients with local eczematous skin and skin infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Single Intra-articular Injection of Adipose-tissue-derived Total-Stromal-cells (TOST) Therapy in Knee Osteoarthritis
In this phase II Randomized Clinical Trial (RCT), impacts of a single Intra-articular injection of autologous adipose tissue derive total-stromal-cells (TOST) on knee pain, physical function, stiffness, and cartilage thickness assessed and compared changes before and after intervention.
Individuals with knee osteoarthritis (KOA) diagnosed by using the American College of Rheumatology (ACR) criteria for Osteoarthritis knee were included in the study. Kellgren-Lawrence (KL) radiological scores were used to define radiological changes and high-frequency musculoskeletal ultrasonogram (MSUS) was used to measure cartilage thickness.
Read the detailed description
A phase II randomized clinical trial (RCT) was performed with primary Knee osteoarthritis (KOA) attended in the department of physical medicine and rehabilitation, BSMMU, between January 2018 and December 2021. Approval was obtained from the institutional review board of BSMMU for this clinical trial (Reference No: BSMMU/2018/25, dated 01/01/2018). Impacts of a single intra-articular (IA) injection of autologous adipose tissue derived total-stromal-cells (TOST) containing mesenchymal stem cells on pain, physical function, stiffness, and cartilage thickness assessed and compared before and after intervention. Patients satisfied the American College of Rheumatology (ACR) criteria for osteoarthritis (OA) knee included in the study. Kellgren-Lawrence (KL) radiological scores were used to define OA grade; however, high-frequency musculoskeletal ultrasonogram (MSUS) was used to measure cartilage thickness. There is no standard protocol to follow while assessing cartilage thickness; however, recent work of Podlipska and co-workers would be a worth consideration for using adipose tissue for cartilage regeneration. As medial tibio-femoral joint is the most commonly involved in KOA, here, we consider medial femoral cartilage thickness. The assessment used a commercially available ultrasound device (Samsung Accuvix, 2010, origin- South Korea) with a 15 megahertz linear transducer ML6-15. The patient was positioned supine with the knee in full flexion. A proximal-distal probe sweeping over the anterior-central knee area, medial femoral articular cartilage imaged in an axial plane. Degenerated cartilage signified either loss of surface sharpness or increased inner echogenicity; local or total thinning of articular cartilage. The definitions for articular cartilage degeneration are as follows: Grade 0 - a monotonous anechoic band with sharp hyperechoic anterior and posterior interfaces, Grade 1 - loss of the average sharpness of cartilage interfaces and or increased echogenicity of the cartilage, Grade 2a - grade 1 plus thinning of articular cartilage less than 50%, Grade 2b - more than 50% but less than 100% thinning of articular cartilage, Grade 3 -100% local loss of the cartilage tissue.
A total of thirty KOA was randomly divided into two groups - case and control. Both groups received conventional care for KOA (acetaminophen 1 gram thrice daily for 14 days, quadriceps strengthening exercises, aerobic exercise, mind-body, proprioception, mechanical diagnosis, and therapy (MDT) exercises, and activities of daily living (ADL) modifications4, 18-20. Fifteen received six milliliters (ml) single-dose of autologous adipose tissue derived total-stromal-cells (TOST) and 3 ml activated PRP). PRP was activated with 0.1 ml calcium gluconate per 0.9 ml of PRP (1:9 ratio). However, no orthobiological product was given in another fifteen participants.
- Conditions
- Osteoarthritis Knees
- Being tested
- Adipose Tissue derived Total-Stromal-Cells (TOST)
- Keywords
- Osteoarthritis, Adipose Tissue, TOST, Stem Cell
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose Tissue derived Total-Stromal-Cells (TOST)Biological
Single dose autologous aAdipose Tissue derived Total-Stromal-Cells (TOST) containing mesenchymal stem cell was injected in each knee of the participants having knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Adipose Tissue derived Total-Stromal-Cells (TOST) | Experimental | Adipose Tissue derived Total-Stromal-Cells (TOST) containing mesenchymal stem cells plus standard conservative care. Receives: Biological: Adipose Tissue derived Total-Stromal-Cells (TOST) |
| Control | No intervention | Standard Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain intensity
Changes in pain intensity are assessed from baseline and at week 4, 12, and 24 using Visual Analogue scale (VAS) [0-10 cm scale], where score '0' denotes no pain and 10 means worst pain.
Measured: Before treatment and after treatment at week 4, 12, and 24
Changes in Physical functioning of knee joints.
Changes in Physical functioning of knee joints were measured by The Western Ontario and McMaster Universities Arthritis Index (WOMAC). There are 17 items consist in WOMAC physical function such as Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. Each item is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The WOMAC physical score ranges between 0 and 68. The lower score means better knee functioning.
Measured: Before treatment and after treatment at week 4, 12, and 24
Changes in femoral cartilage thickness
Changes in cartilage thickness was measured from baseline to 24 weeks of the study period using high frequency ultrasound 15 MHz (6-15 MHz) transducer (Samsung Accuvix, 2010, South Korea). Mean femoral cartilage was considered for analysis
Measured: Baseline and 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Jan 2018
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis KneesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Dhaka Medical College
- 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
- NCT05280002
- Sponsor's protocol ID
- BSMMU/2018/25
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Decision is required from all the investigators on consensus basis.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Single Intra-articular Injection of Adipose-tissue-derived Total-Stromal-cells (TOST) Therapy in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05280002
- Acronym / sponsor ID
- BSMMU/2018/25
- Conditions
- Osteoarthritis Knees
- Keywords
- Osteoarthritis, Adipose Tissue, TOST, Stem Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Collaborators
- Dhaka Medical College
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 Mar 2022 (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.
In this phase II Randomized Clinical Trial (RCT), impacts of a single Intra-articular injection of autologous adipose tissue derive total-stromal-cells (TOST) on knee pain, physical function, stiffness, and cartilage thickness assessed and compared changes before and after intervention.
Individuals with knee osteoarthritis (KOA) diagnosed by using the American College of Rheumatology (ACR) criteria for Osteoarthritis knee were included in the study. Kellgren-Lawrence (KL) radiological scores were used to define radiological changes and high-frequency musculoskeletal ultrasonogram (MSUS) was used to measure cartilage thickness.
Detailed description
A phase II randomized clinical trial (RCT) was performed with primary Knee osteoarthritis (KOA) attended in the department of physical medicine and rehabilitation, BSMMU, between January 2018 and December 2021. Approval was obtained from the institutional review board of BSMMU for this clinical trial (Reference No: BSMMU/2018/25, dated 01/01/2018). Impacts of a single intra-articular (IA) injection of autologous adipose tissue derived total-stromal-cells (TOST) containing mesenchymal stem cells on pain, physical function, stiffness, and cartilage thickness assessed and compared before and after intervention. Patients satisfied the American College of Rheumatology (ACR) criteria for osteoarthritis (OA) knee included in the study. Kellgren-Lawrence (KL) radiological scores were used to define OA grade; however, high-frequency musculoskeletal ultrasonogram (MSUS) was used to measure cartilage thickness. There is no standard protocol to follow while assessing cartilage thickness; however, recent work of Podlipska and co-workers would be a worth consideration for using adipose tissue for cartilage regeneration. As medial tibio-femoral joint is the most commonly involved in KOA, here, we consider medial femoral cartilage thickness. The assessment used a commercially available ultrasound device (Samsung Accuvix, 2010, origin- South Korea) with a 15 megahertz linear transducer ML6-15. The patient was positioned supine with the knee in full flexion. A proximal-distal probe sweeping over the anterior-central knee area, medial femoral articular cartilage imaged in an axial plane. Degenerated cartilage signified either loss of surface sharpness or increased inner echogenicity; local or total thinning of articular cartilage. The definitions for articular cartilage degeneration are as follows: Grade 0 - a monotonous anechoic band with sharp hyperechoic anterior and posterior interfaces, Grade 1 - loss of the average sharpness of cartilage interfaces and or increased echogenicity of the cartilage, Grade 2a - grade 1 plus thinning of articular cartilage less than 50%, Grade 2b - more than 50% but less than 100% thinning of articular cartilage, Grade 3 -100% local loss of the cartilage tissue.
A total of thirty KOA was randomly divided into two groups - case and control. Both groups received conventional care for KOA (acetaminophen 1 gram thrice daily for 14 days, quadriceps strengthening exercises, aerobic exercise, mind-body, proprioception, mechanical diagnosis, and therapy (MDT) exercises, and activities of daily living (ADL) modifications4, 18-20. Fifteen received six milliliters (ml) single-dose of autologous adipose tissue derived total-stromal-cells (TOST) and 3 ml activated PRP). PRP was activated with 0.1 ml calcium gluconate per 0.9 ml of PRP (1:9 ratio). However, no orthobiological product was given in another fifteen participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adipose Tissue derived Total-Stromal-Cells (TOST) | Experimental | Biological: Adipose Tissue derived Total-Stromal-Cells (TOST)Adipose Tissue derived Total-Stromal-Cells (TOST) containing mesenchymal stem cells plus standard conservative care. |
| Control | No intervention | –Standard Conventional Treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary KOA with KL-grade II and III radiological changes
Key exclusion criteria (3 listed)
- KOA received IA steroid, viscosupplementation, or PRP injection or undergone knee surgery within the last six months.
- Patients with septic and tubercular arthritis, post-traumatic hemarthrosis, unstable knee joint due to anterior cruciate ligament (ACL) injury, malignancy, autoinflammatory arthritis (gout), inflammatory disease (rheumatoid arthritis, psoriatic arthritis, reactive, and ankylosing spondylitis), and charcot arthropathy.
- Patients with local eczematous skin and skin infection
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 |
|---|---|---|
| Adipose Tissue derived Total-Stromal-Cells (TOST)Single dose autologous aAdipose Tissue derived Total-Stromal-Cells (TOST) containing mesenchymal stem cell was injected in each knee of the participants having knee osteoarthritis. | Biological | Adipose Tissue derived Total-Stromal-Cells (TOST) |
Primary outcome
Changes in pain intensity
Time frame: Before treatment and after treatment at week 4, 12, and 24
Changes in pain intensity are assessed from baseline and at week 4, 12, and 24 using Visual Analogue scale (VAS) [0-10 cm scale], where score '0' denotes no pain and 10 means worst pain.
Changes in Physical functioning of knee joints.
Time frame: Before treatment and after treatment at week 4, 12, and 24
Changes in Physical functioning of knee joints were measured by The Western Ontario and McMaster Universities Arthritis Index (WOMAC). There are 17 items consist in WOMAC physical function such as Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. Each item is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The WOMAC physical score ranges between 0 and 68. The lower score means better knee functioning.
Changes in femoral cartilage thickness
Time frame: Baseline and 24 weeks after treatment
Changes in cartilage thickness was measured from baseline to 24 weeks of the study period using high frequency ultrasound 15 MHz (6-15 MHz) transducer (Samsung Accuvix, 2010, South Korea). Mean femoral cartilage was considered for analysis
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 15 Mar 2022.
- Individual participant dataSharing planned: No. Decision is required from all the investigators on consensus basis.
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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 study testing Adipose Tissue derived Total-Stromal-Cells (TOST) in people with Osteoarthritis Knees, 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 1 inclusion and 3 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 15 Mar 2022. 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 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?
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?
Changes in pain intensity (time frame: Before treatment and after treatment at week 4, 12, and 24). 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?
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 15 Mar 2022.