Osteoarthritis KneePhase 1/2NCT06688318
Effectivity of Allogenic Umbilical Cord Mesenchymal Stem Cells Conditioned Media for Osteoarthritis of the Knee Joint
A Phase 1/2 study testing Intra-articular secretome injection therapy in people with Osteoarthritis Knee, run by Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia at 1 site in Indonesia.
Trial summary
Osteoarthritis (OA) is a joint disorder that often occurs and causes disability. This disorder is characterized by an inflammatory reaction in the synovial joints accompanied by a gradual degeneration process in the articular cartilage and sub-chondral bone. Read more about this study
- Who is it for?
- Ages 45 months and older
- Conditions the study is for
- Osteoarthritis Knee
- What is being tested?
- Intra-articular secretome injection therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Apr 2024to 1 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 45 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age over 45 years
- primary knee joint OA Kellgrance-Lawrence grade 2 or 3,
- never had surgery or intra-articular injection before,
Who cannot join
- currently experiencing local infections and/or systemic infections,
- have a history of autoimmune disorders or immunodeficiency,
- have had surgery or injections on the knee joint,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectivity of Allogenic Umbilical Cord Mesenchymal Stem Cells Conditioned Media for Osteoarthritis of the Knee Joint: A Clinical Study of Functional Score and Magnetic Resonance Imaging Evaluation Using CartiGram
Osteoarthritis (OA) is a joint disorder that often occurs and causes disability. This disorder is characterized by an inflammatory reaction in the synovial joints accompanied by a gradual degeneration process in the articular cartilage and sub-chondral bone. Current research has discovered that stem cells produce conditioned media (secretome, extra vesicles, and exosomes) that have tissue regeneration, immunomodulation, anti-inflammatory, and anti-apoptotic capabilities. Research on conditioned media for umbilical cord mesenchymal stem cells is still at the in vivo stage in experimental animals. For this reason, this study aims to conduct clinical experimental research (translational study) in patients with knee joint OA who were given umbilical cord mesenchymal stem cell conditioned media via intra-articular injection.
Read the detailed description
The research was conducted as a clinical trial and translational study, involving a single group treated with intra-articular secretome injection therapy derived from hypoxic umbilical cord mesenchymal stem cell conditioned media.
This study explores the clinical application of conditioned media from umbilical cord mesenchymal stem cells for treating knee OA. Our preliminary clinical trial involves administering this conditioned media via intra-articular injections to patients, followed by assessments using functional scores and MRI with T2 mapping sequence. This approach aims to harness the therapeutic potential of MSC derivatives in a clinical setting, offering a novel and potentially less invasive alternative to conventional OA treatments. The aim of this study is to evaluate the effectiveness of intra-articular injections of conditioned media from umbilical cord mesenchymal stem cells in improving knee joint function and structural integrity in patients with osteoarthritis, as assessed by MRI and functional scoring.
- Conditions
- Osteoarthritis Knee
- Being tested
- Intra-articular secretome injection therapy
- Keywords
- osteoarthritis knee, Mesenchymal Stem Cell, conditioned media
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular secretome injection therapyBiological
Intra-articular secretome injection therapy from hypoxic umbilical cord mesenchymal stem cell conditioned media
| Study group | Role | What they receive |
|---|---|---|
| OA Knee | Experimental | Knee Intraarticular Conditioned Media Injection Receives: Biological: Intra-articular secretome injection therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Score 1. Knee Injury and Osteoarthritis Outcome Score (KOOS),
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: 2,4,6 Months
Functional Score 2. Knee Society Score (KSS)
The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Measured: 2,4,6 Months
Functional Score 3. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score
Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Measured: 2,4,6 Months
Secondary outcomes (1)
Radiographic Evaluation
Magnetic Resonance Imaging Evaluation using CartiGram
Measured: 2,4,6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start3 Apr 2024
- Primary completion1 Sep 2024
- Study completion1 Dec 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bintang Soetjahjo, SpOT (K), MD. PhD, Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
- Investigators
- Bintang S Bintang Soetjahjo, MD, PhD, Principal investigator, Dr. Moewardi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688318
- Sponsor's protocol ID
- 932/VII/HREC/2024
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of Allogenic Umbilical Cord Mesenchymal Stem Cells Conditioned Media for Osteoarthritis of the Knee Joint: A Clinical Study of Functional Score and Magnetic Resonance Imaging Evaluation Using CartiGram
- ClinicalTrials.gov ID
- NCT06688318
- Acronym / sponsor ID
- 932/VII/HREC/2024
- Conditions
- Osteoarthritis Knee
- Keywords
- osteoarthritis knee, Mesenchymal Stem Cell, conditioned media
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, IndonesiaOther government
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 14 Nov 2024 (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 a joint disorder that often occurs and causes disability. This disorder is characterized by an inflammatory reaction in the synovial joints accompanied by a gradual degeneration process in the articular cartilage and sub-chondral bone. Current research has discovered that stem cells produce conditioned media (secretome, extra vesicles, and exosomes) that have tissue regeneration, immunomodulation, anti-inflammatory, and anti-apoptotic capabilities. Research on conditioned media for umbilical cord mesenchymal stem cells is still at the in vivo stage in experimental animals. For this reason, this study aims to conduct clinical experimental research (translational study) in patients with knee joint OA who were given umbilical cord mesenchymal stem cell conditioned media via intra-articular injection.
Detailed description
The research was conducted as a clinical trial and translational study, involving a single group treated with intra-articular secretome injection therapy derived from hypoxic umbilical cord mesenchymal stem cell conditioned media.
This study explores the clinical application of conditioned media from umbilical cord mesenchymal stem cells for treating knee OA. Our preliminary clinical trial involves administering this conditioned media via intra-articular injections to patients, followed by assessments using functional scores and MRI with T2 mapping sequence. This approach aims to harness the therapeutic potential of MSC derivatives in a clinical setting, offering a novel and potentially less invasive alternative to conventional OA treatments. The aim of this study is to evaluate the effectiveness of intra-articular injections of conditioned media from umbilical cord mesenchymal stem cells in improving knee joint function and structural integrity in patients with osteoarthritis, as assessed by MRI and functional scoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OA Knee | Experimental | Biological: Intra-articular secretome injection therapyKnee Intraarticular Conditioned Media Injection |
Who may qualify
- Ages
- 45 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age over 45 years
- primary knee joint OA Kellgrance-Lawrence grade 2 or 3,
- never had surgery or intra-articular injection before,
Key exclusion criteria (3 listed)
- currently experiencing local infections and/or systemic infections,
- have a history of autoimmune disorders or immunodeficiency,
- have had surgery or injections on the knee 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 |
|---|---|---|
| Intra-articular secretome injection therapyIntra-articular secretome injection therapy from hypoxic umbilical cord mesenchymal stem cell conditioned media | Biological | OA Knee |
Primary outcome
Functional Score 1. Knee Injury and Osteoarthritis Outcome Score (KOOS),
Time frame: 2,4,6 Months
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Functional Score 2. Knee Society Score (KSS)
Time frame: 2,4,6 Months
The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Functional Score 3. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score
Time frame: 2,4,6 Months
Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
1 secondary outcome
Radiographic Evaluation
Time frame: 2,4,6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Bintang S Bintang Soetjahjo, MD, PhD principal investigator
Dr. Moewardi Hospital
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 Intra-articular secretome injection therapy in people with Osteoarthritis Knee, run by Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia at 1 site in Indonesia.
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 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: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. 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 Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Functional Score 1. Knee Injury and Osteoarthritis Outcome Score (KOOS), (time frame: 2,4,6 Months). 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 Nov 2024.