Knee Osteoarthritis (Knee OA)Phase 2/3SECRET-OANCT07337863
Phase II/III Randomized Trial of UC-MSC Secretome vs Sodium Hyaluronate in Knee Osteoarthritis
A Phase 2/3 study testing UC-MSC-Derived Secretome and Sodium Hyaluronate (Hyalein) in people with Knee Osteoarthritis (Knee OA), run by Universitas Sriwijaya at 1 site in Indonesia.
Trial summary
This study is a randomized, double-blind, multicenter Phase II/III clinical trial designed to evaluate the effectiveness and safety of umbilical cord-derived mesenchymal stem cell (UC-MSC) secretome compared with sodium hyaluronate in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- UC-MSC-Derived Secretome and Sodium Hyaluronate (Hyalein)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Aug 2026to 24 Dec 2027
- Phase
- Phase 2/3
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with primary OA in one or both knees based on American College of Rheumatology (Clinical and Rheumatology criteria). If both knees have OA, the knee with the OA grade that falls within the inclusion criteria (grade 2-3) will be selected. If both knees meet the inclusion criteria, the knee with the highest grade and the one that is most uncomfortable will be chosen.
- Males or females in the age range 40-70 years
- Symptomatic knee OA (defined by pain at the affected joint for at least 3 months before inclusion and visual analog scale 40 - 70 mm on a 100 mm Visual Analog Scale (VAS).
- Radiographic evidence of grade 2 to 3 osteoarthritis (OA) based on Kellgren and Lawrence radiographic criteria.
- Body mass index between 18 - 30 kg/m2
- Female participants of childbearing age who agreed to use accepted methods of contraception during the course of the study.
- Ability to provide written informed consent and willing to participate the study
Who cannot join
- Participants who, based on physical examination and clinical history (anamnesis), are in the active or acute phase of cardiac, pulmonary, hematological, hepatic, renal, systemic autoimmune, immunodeficiency, or coagulation disorders that may interfere with the administration of the study drug (Secretome or Sodium Hyaluronate) will be excluded,
- Diagnosed with a meniscal rupture based on clinical history (anamnesis) and physical examination. If the anamnesis and physical examination show symptoms and signs of a meniscal rupture, further evaluation will be performed using ultrasound (USG),
- Participants with significant axial deviation, defined by valgus or varus deformity observed during physical examination, will be excluded,
- Participants with other pathological lesions on knee X-rays from the screening examination will also be excluded,
- History of any form of secondary arthritis in the knee due to trauma,
- History of surgery or major trauma to the knee joint
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- Has knee effusion,
- Has any other inflammatory disorder of the knee joint
- Diagnosed with active malignancy.
- History of stem cell or secretome therapy.
- Intra-articular injection of corticosteroid and/or prior treatment with Sodium Hyaluronate and/or platelet rich plasma (PRP) in past 3 months.
- Use of NSAIDs and/or chondroprotective supplements, such as glucosamine and chondroitin sulfate, within 7 days before the trial, whether used orally, topically, or via injection,
- Undergoing immunosuppressive therapy, or anticoagulant therapy, or corticosteroid therapy.
- For women of child-bearing potential: positive pregnancy test or lactating (females who were planning pregnancy within the next year were excluded).
- Enrolled in any other clinical trials within the past four weeks.
- The principal investigator considers that the participant is ineligible for the clinical trial due to any reasons other than those listed above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
RSUP Dr. Mohammad Hoesin Palembang
Palembang, South Sumatera
Radiyati Umi Partan, MD, PhD, +62812-7811-6601, radiyati.u.p@fk.unsri.ac.id
About this study
Official title: A Phase II/III Randomized Double-Blind Multicenter Study Comparing UC-MSC-Derived Secretome and Sodium Hyaluronate on Pain and Function in Patients With Kellgren-Lawrence Grade 2-3 Knee Osteoarthritis
This study is a randomized, double-blind, multicenter Phase II/III clinical trial designed to evaluate the effectiveness and safety of umbilical cord-derived mesenchymal stem cell (UC-MSC) secretome compared with sodium hyaluronate in patients with knee osteoarthritis. Knee osteoarthritis is a common degenerative joint disease that causes chronic pain and functional limitation. Participants will be randomly assigned to receive intra-articular injections of either UC-MSC-derived secretome or sodium hyaluronate. The study aims to assess improvements in knee pain, physical function, and overall clinical outcomes, as well as to evaluate the safety of the interventions over the study period.
Read the detailed description
This multicenter, randomized, double-blind Phase II/III clinical study aims to compare the efficacy and safety of intra-articular UC-MSC-derived secretome with sodium hyaluronate in patients with Kellgren-Lawrence grade 2-3 knee osteoarthritis. Eligible participants will be randomly allocated to one of two treatment arms. Clinical outcomes will be evaluated using validated pain and functional assessment tools at predefined time points. Safety assessments will include monitoring of adverse events throughout the study period. The results of this study are expected to provide evidence regarding the potential role of UC-MSC-derived secretome as an alternative therapeutic option for knee osteoarthritis.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- UC-MSC-Derived Secretome, Sodium Hyaluronate (Hyalein)
- Keywords
- Knee Osteoarthritis, UC-MSC Secretome, Randomized Controlled Trial, Sodium Hyaluronate, Intra-articular Injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSC-Derived SecretomeBiological
Umbilical cord-derived mesenchymal stem cell secretome administered via intra-articular injection according to the study protocol.
Sodium Hyaluronate (Hyalein)Drug
Also called Sodium Hyaluronate
Sodium hyaluronate administered via intra-articular injection as an active comparator.
| Study group | Role | What they receive |
|---|---|---|
| UC-MSC-Derived Secretome | Experimental | Participants receive intra-articular injection of UC-MSC-derived secretome Receives: Drug: Sodium Hyaluronate (Hyalein) |
| Sodium Hyaluronate | Active comparator | Participants receive intra-articular injection of sodium hyaluronate Receives: Biological: UC-MSC-Derived Secretome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in WOMAC Pain Subscale Score
Change from baseline in knee pain assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale.
Measured: Baseline to Week 24
Secondary outcomes (1)
Change From Baseline in WOMAC Total Score
Change from baseline in overall knee pain, stiffness, and physical function assessed using WOMAC total score.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start30 Aug 2026 (estimated)
- Primary completion16 Sep 2026 (estimated)
- Study completion24 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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
- Model description
- In this parallel assignment study, participants will be randomized to receive intra-articular injections of either UC-MSC-derived secretome or sodium hyaluronate.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Collaborators
- PT Bifarma Adiluhung
- Responsible party
- Sponsor
- Investigators
- Radiyati Umi Partan, MD, PhD, Study chair, Universitas Sriwijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337863
- Sponsor's protocol ID
- PML-BFA-04-2024
- Other IDs
- PML-BFA-04-2024
- Acronym
- SECRET-OA
- Status last verified
- May 2026
- First submitted
- 1 Jan 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary outcome measures, including demographic characteristics, baseline clinical data, outcome scores, and adverse event data, will be shared. All data will be fully anonymized, with no direct identifiers, in accordance with applicable ethical and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Randomized Double-Blind Multicenter Study Comparing UC-MSC-Derived Secretome and Sodium Hyaluronate on Pain and Function in Patients With Kellgren-Lawrence Grade 2-3 Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07337863
- Acronym / sponsor ID
- SECRET-OA / PML-BFA-04-2024
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Knee Osteoarthritis, UC-MSC Secretome, Randomized Controlled Trial, Sodium Hyaluronate, Intra-articular Injection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Collaborators
- PT Bifarma Adiluhung
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- 24 Dec 2027 (estimated)
- First posted
- 13 Jan 2026 (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.
This study is a randomized, double-blind, multicenter Phase II/III clinical trial designed to evaluate the effectiveness and safety of umbilical cord-derived mesenchymal stem cell (UC-MSC) secretome compared with sodium hyaluronate in patients with knee osteoarthritis. Knee osteoarthritis is a common degenerative joint disease that causes chronic pain and functional limitation. Participants will be randomly assigned to receive intra-articular injections of either UC-MSC-derived secretome or sodium hyaluronate. The study aims to assess improvements in knee pain, physical function, and overall clinical outcomes, as well as to evaluate the safety of the interventions over the study period.
Detailed description
This multicenter, randomized, double-blind Phase II/III clinical study aims to compare the efficacy and safety of intra-articular UC-MSC-derived secretome with sodium hyaluronate in patients with Kellgren-Lawrence grade 2-3 knee osteoarthritis. Eligible participants will be randomly allocated to one of two treatment arms. Clinical outcomes will be evaluated using validated pain and functional assessment tools at predefined time points. Safety assessments will include monitoring of adverse events throughout the study period. The results of this study are expected to provide evidence regarding the potential role of UC-MSC-derived secretome as an alternative therapeutic option for knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In this parallel assignment study, participants will be randomized to receive intra-articular injections of either UC-MSC-derived secretome or sodium hyaluronate.
| Arm | Type | Receives |
|---|---|---|
| UC-MSC-Derived Secretome | Experimental | Drug: Sodium Hyaluronate (Hyalein)Participants receive intra-articular injection of UC-MSC-derived secretome |
| Sodium Hyaluronate | Active comparator | Biological: UC-MSC-Derived SecretomeParticipants receive intra-articular injection of sodium hyaluronate |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with primary OA in one or both knees based on American College of Rheumatology (Clinical and Rheumatology criteria). If both knees have OA, the knee with the OA grade that falls within the inclusion criteria (grade 2-3) will be selected. If both knees meet the inclusion criteria, the knee with the highest grade and the one that is most uncomfortable will be chosen.
- Males or females in the age range 40-70 years
- Symptomatic knee OA (defined by pain at the affected joint for at least 3 months before inclusion and visual analog scale 40 - 70 mm on a 100 mm Visual Analog Scale (VAS).
- Radiographic evidence of grade 2 to 3 osteoarthritis (OA) based on Kellgren and Lawrence radiographic criteria.
- Body mass index between 18 - 30 kg/m2
Key exclusion criteria (16 listed)
- Participants who, based on physical examination and clinical history (anamnesis), are in the active or acute phase of cardiac, pulmonary, hematological, hepatic, renal, systemic autoimmune, immunodeficiency, or coagulation disorders that may interfere with the administration of the study drug (Secretome or Sodium Hyaluronate) will be excluded,
- Diagnosed with a meniscal rupture based on clinical history (anamnesis) and physical examination. If the anamnesis and physical examination show symptoms and signs of a meniscal rupture, further evaluation will be performed using ultrasound (USG),
- Participants with significant axial deviation, defined by valgus or varus deformity observed during physical examination, will be excluded,
- Participants with other pathological lesions on knee X-rays from the screening examination will also be excluded,
- History of any form of secondary arthritis in the knee due to trauma,
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 |
|---|---|---|
| UC-MSC-Derived SecretomeUmbilical cord-derived mesenchymal stem cell secretome administered via intra-articular injection according to the study protocol. | Biological | Sodium Hyaluronate |
| Sodium Hyaluronate (Hyalein)Also: Sodium HyaluronateSodium hyaluronate administered via intra-articular injection as an active comparator. | Drug | UC-MSC-Derived Secretome |
Primary outcome
Change From Baseline in WOMAC Pain Subscale Score
Time frame: Baseline to Week 24
Change from baseline in knee pain assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale.
1 secondary outcome
Change From Baseline in WOMAC Total Score
Time frame: Baseline to Week 12
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 12 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary outcome measures, including demographic characteristics, baseline clinical data, outcome scores, and adverse event data, will be shared. All data will be fully anonymized, with no direct identifiers, in accordance with applicable ethical and regulatory requirements.
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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.
Radiyati Umi Partan, MD, PhD study chair
Universitas Sriwijaya
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 UC-MSC-Derived Secretome and Sodium Hyaluronate (Hyalein) in people with Knee Osteoarthritis (Knee OA), run by Universitas Sriwijaya 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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 12 May 2026. 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 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?
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?
Contact Rudi Erwin Kurniawan, MD, MH (+6282166114111, dr.rudierwin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in WOMAC Pain Subscale Score (time frame: Baseline to Week 24). 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 12 May 2026.