Osteoarthritis, KneePhase 1/2OANCT04314661
Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis
A Phase 1/2 study testing Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome, Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome and Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome in people with Osteoarthritis, Knee, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
Trial summary
This study aims to compare the efficacy of Umbilical Cord Mesenchymal Stem Cell and secretome between arthroscopy and without arthroscopy intervention in OA patients. This study has 4 arms namely Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome, Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome and Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Aug 2020to 8 Dec 2024
- Phase
- Phase 1/2
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 55-70 years
- Suffering from grade 2-3 OA was identified by two observers who differed accordingly Kellgren-Lawrence research scale
- Absence of local or general infections
- Haematological and biochemical analysis without significant changes being made cause contraindications
- Patients can understand the nature of the study
- Written informed consent is given to patients
Who cannot join
- Patients are not willing to obey the study protocol
- There are signs of infection or positive serology for HIV, hepatitis and syphilis
- There is a history of cancer both in the family and yourself and the value of the examination tumour marker exceeds normal limits
- There is a congenital disease that causes significant deformity of the knee can interfere with cell applications and interpret results
- Articular injection of the knee by any drug during the previous 3 months
- Participate in any clinical trial or treatment 30 days before the study
- Other conditions may, according to medical criteria, not support participation in this research
- Patients are subordinates or low ranking members
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Osteoarthritis Therapy Using Combination of Mesenchymal Stem Cell (MSC) and Conditioned Medium (CM): A Comparative Study on Arthroscopy and Non-Arthroscopy
This study aims to compare the efficacy of Umbilical Cord Mesenchymal Stem Cell and secretome between arthroscopy and without arthroscopy intervention in OA patients. This study has 4 arms namely Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning.
Read the detailed description
The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after injection.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome, Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome, Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome, Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome
- Keywords
- Osteoarthritis, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium
- 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.
Arthroscopy with Mesenchymal Stem Cells + Secretome + SecretomeBiological
After Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.
Arthroscopy with Secretome + Mesenchymal Stem Cells + SecretomeBiological
After Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.
Non Arthroscopy with Mesenchymal Stem Cells + Secretome + SecretomeBiological
Also called Secretome
Without Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.
Non Arthroscopy with Secretome + Mesenchymal Stem Cells + SecretomeBiological
Without Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopy + Booster | Experimental | After arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection. Receives: Biological: Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome |
| Arthroscopy + Pre-Conditioning | Experimental | After arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection. Receives: Biological: Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome |
| Non Arthroscopy + Booster | Experimental | Without arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection. Receives: Biological: Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome |
| Non Arthroscopy + Pre-Conditioning | Experimental | Without arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection. Receives: Biological: Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Measured: 1 month after injection
Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Measured: 3 month after injection
Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Measured: 6 month after injection
Western Ontario and McMaster Universities Osteoarthritis Index
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Measured: 1 month after injection
Western Ontario and McMaster Universities Osteoarthritis Index
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Measured: 3 month after injection
Western Ontario and McMaster Universities Osteoarthritis Index
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Measured: 6 month after injection
Secondary outcomes (4)
Laboratory Asessment
COMP, MMP-13, IL-6
Measured: 2 weeks after injection
Laboratory Asessment
COMP, MMP-13, IL-6
Measured: 1 month after injection
Laboratory Asessment
COMP, MMP-13, IL-6
Measured: 3 months after injection
Magnetic Resonance Imaging (MRI) T2 mapping
MRI T2 mapping is used for cartilage evaluation
Measured: 6 month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start3 Aug 2020
- Primary completion8 Jul 2024
- Study completion8 Dec 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314661
- Sponsor's protocol ID
- CT/OA/02/2022
- Acronym
- OA
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2020
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Osteoarthritis Therapy Using Combination of Mesenchymal Stem Cell (MSC) and Conditioned Medium (CM): A Comparative Study on Arthroscopy and Non-Arthroscopy
- ClinicalTrials.gov ID
- NCT04314661
- Acronym / sponsor ID
- OA / CT/OA/02/2022
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Dec 2024 (actual)
- First posted
- 19 Mar 2020 (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 aims to compare the efficacy of Umbilical Cord Mesenchymal Stem Cell and secretome between arthroscopy and without arthroscopy intervention in OA patients. This study has 4 arms namely Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning.
Detailed description
The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arthroscopy + Booster | Experimental | Biological: Arthroscopy with Mesenchymal Stem Cells + Secretome + SecretomeAfter arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection. |
| Arthroscopy + Pre-Conditioning | Experimental | Biological: Arthroscopy with Secretome + Mesenchymal Stem Cells + SecretomeAfter arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection. |
| Non Arthroscopy + Booster | Experimental | Biological: Non Arthroscopy with Mesenchymal Stem Cells + Secretome + SecretomeWithout arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection. |
| Non Arthroscopy + Pre-Conditioning | Experimental | Biological: Non Arthroscopy with Secretome + Mesenchymal Stem Cells + SecretomeWithout arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 55-70 years
- Suffering from grade 2-3 OA was identified by two observers who differed accordingly Kellgren-Lawrence research scale
- Absence of local or general infections
- Haematological and biochemical analysis without significant changes being made cause contraindications
- Patients can understand the nature of the study
Key exclusion criteria (8 listed)
- Patients are not willing to obey the study protocol
- There are signs of infection or positive serology for HIV, hepatitis and syphilis
- There is a history of cancer both in the family and yourself and the value of the examination tumour marker exceeds normal limits
- There is a congenital disease that causes significant deformity of the knee can interfere with cell applications and interpret results
- Articular injection of the knee by any drug during the previous 3 months
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 |
|---|---|---|
| Arthroscopy with Mesenchymal Stem Cells + Secretome + SecretomeAfter Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular. | Biological | Arthroscopy + Booster |
| Arthroscopy with Secretome + Mesenchymal Stem Cells + SecretomeAfter Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular. | Biological | Arthroscopy + Pre-Conditioning |
| Non Arthroscopy with Mesenchymal Stem Cells + Secretome + SecretomeAlso: SecretomeWithout Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular. | Biological | Non Arthroscopy + Booster |
| Non Arthroscopy with Secretome + Mesenchymal Stem Cells + SecretomeWithout Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular. | Biological | Non Arthroscopy + Pre-Conditioning |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 1 month after injection
To asses pain score, score 1(good)-10(worst)
Visual Analog Scale (VAS)
Time frame: 3 month after injection
To asses pain score, score 1(good)-10(worst)
Visual Analog Scale (VAS)
Time frame: 6 month after injection
To asses pain score, score 1(good)-10(worst)
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 1 month after injection
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 3 month after injection
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 6 month after injection
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
4 secondary outcomes
Laboratory Asessment
Time frame: 2 weeks after injection
Laboratory Asessment
Time frame: 1 month after injection
Laboratory Asessment
Time frame: 3 months after injection
Magnetic Resonance Imaging (MRI) T2 mapping
Time frame: 6 month after injection
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 25 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome, Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome and Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome in people with Osteoarthritis, Knee, run by PT. Prodia Stem Cell 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 6 inclusion and 8 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 25 Feb 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 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?
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?
Visual Analog Scale (VAS) (time frame: 1 month after injection). The study lists 6 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 25 Feb 2026.