Osteoarthritis (OA)Early Phase 1PRGFSECKOANCT07157891
Investigating the Safety and Regenerative Potential of MSC-Derived Secretome Combined With PRGF in Knee Osteoarthritis
A Early Phase 1 study testing MSC-Derived Secretome and MSC-Derived Secretome + Autologous PRGF in people with Osteoarthritis (OA) and Knee Injury, run by University of the Punjab.
Trial summary
This Phase I/II randomized clinical trial investigates the safety, feasibility, and early regenerative potential of intra-articular administration of mesenchymal stem cell (MSC)-derived secretome combined with Plasma Rich in Growth Factors (PRGF) in patients with knee osteoarthritis (KOA). Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Osteoarthritis (OA), Knee Injury, Cartilage Degeneration
- What is being tested?
- MSC-Derived Secretome and MSC-Derived Secretome + Autologous PRGF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2025to 11 Dec 2028
- Phase
- Early Phase 1
- 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Following is the inclusion criteria for the enrolment of patients affected with damaged cartilage in this study:
- Diagnosed with primary OA in one or both knees based on American College of Rheumatology criteria
- Grade I and II Arthritis
- Joint pain ≥ 20mm measured by visual analogue scale
- Age ranges from 30-55 years of age
- BMI 27.12 ± 4.38
- Patients with no previous surgical interventions to lower limb
- Willing to participate in the study
Who cannot join
- • Secondary OA due to trauma, infection, rheumatoid arthritis, congenital disease or other inflammatory disorders of the knee
- Diagnosed with a systemic autoimmune disorder, immunodeficiency or coagulation disorder
- Had history of malignancy
- History of allergy or allergic constitution
- Pregnant or breastfeeding women.
About this study
This Phase I/II randomized clinical trial investigates the safety, feasibility, and early regenerative potential of intra-articular administration of mesenchymal stem cell (MSC)-derived secretome combined with Plasma Rich in Growth Factors (PRGF) in patients with knee osteoarthritis (KOA). The study aims to assess whether this cell-free, biologically enriched therapeutic combination can reduce pain, improve joint function, and promote cartilage repair.
Read the detailed description
Osteoarthritis (OA) is a chronic, degenerative joint disease characterized by progressive cartilage degradation, joint space narrowing, subchondral bone remodeling, inflammation, and pain that ultimately impair mobility and quality of life. Current treatment options, including analgesics, corticosteroids, and surgery, offer symptomatic relief but do not halt disease progression or restore joint tissue integrity.
Recent advancements in regenerative medicine have highlighted the therapeutic potential of mesenchymal stem cells (MSCs), particularly adipose-derived MSCs (AD-MSCs) and umbilical cord- derived MSCs (UC-MSCs), due to their robust paracrine activity. Rather than relying solely on cell engraftment, MSCs exert their therapeutic effects primarily through their secretome. These are complex mixtures of cytokines, growth factors, extracellular vesicles (EVs), and exosomes. This secretome can promote cartilage repair, reduce inflammation, and modulate immune responses, all without the risks associated with live cell transplantation.
This prospective, interventional study aims to evaluate the safety, tolerability, and early efficacy of intra-articular administration of MSC-derived secretome combined with Plasma Rich in Growth Factors (PRGF) in patients with mild to moderate symptomatic knee osteoarthritis (Kellgren-Lawrence grade II-III).The secretome will be collected from culture of human ADMSCs and UCMSCs grown in GMP-compliant labs, characterized for sterility, protein content, particle size, and bioactivity prior to administration.
Primary outcomes will include pain reduction assessment and any adverse events via Visual Analog Scale (VAS) and WOMAC index. If there will be adverse events, they will also be checked. Secondary outcomes will include functional improvement, cartilage regeneration (X-ray or MRI assessment), and changes in synovial inflammatory biomarkers (e.g., IL-1β, TNF-α, IL-6, MMP-13).
This study hypothesizes that the cell-free combination of MSC secretome and PRGF will offer regenerative benefits in knee OA, potentially improving joint function and structure while minimizing the risks associated with live cell therapies. Findings from this trial will inform the design of future large-scale studies and support the development of secretome-based regenerative therapies for osteoarthritis.
- Conditions
- Osteoarthritis (OA), Knee Injury, Cartilage Degeneration
- Being tested
- MSC-Derived Secretome, MSC-Derived Secretome + Autologous PRGF
- Keywords
- Mesenchymal Stem Cell Secretome, Plasma Rich in Growth Factors (PRGF), Platelet-Rich Plasma (PRP), Knee Osteoarthritis, Intra-articular Injection, Cell-free Therapy, Regenerative Medicine
- Medical subject headings
- Osteoarthritis, Knee Injuries, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC-Derived SecretomeBiological
Also called Conditioned Medium, MSC Secretome Therapy
The secretome will be collected from cultured MSCs under sterile, GMP-compliant conditions and concentrated to retain bioactive molecules. It will be injected into the affected knee under ultrasound guidance.
MSC-Derived Secretome + Autologous PRGFBiological
Also called MSC-Secretome/PRGF Combined Therapy
MSC-derived secretome will be collected from mesenchymal stem cell cultures under sterile, GMP-compliant conditions. Autologous PRP will be prepared from the participant's own peripheral blood using a standardized single-spin centrifugation method and combined with 10% calcium chloride to activate growth factors. Both components will be mixed and administered into the affected joint under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| MSC-Derived Secretome | Experimental | MSC-derived secretome will be administered as intra-articular injections under ultrasound guidance to the affected knee. Injection will be given twice, each after 6 months. Each injection will consist of 2 mL of concentrated MSC-derived secretome. Receives: Biological: MSC-Derived Secretome |
| MSC-Derived Secretome + Autologous PRGF | Experimental | MSC-derived secretome combined with autologous plasma-rich in growth factors plasma (PRGF) will be administered as intra-articular injections under ultrasound guidance to the affected knee. Injections will be given twice, each after 6 months. Each injection will consist of 2 mL of concentrated MSC-derived secretome and 1 mL of autologous PRGF, totaling 3 mL per dose. Receives: Biological: MSC-Derived Secretome + Autologous PRGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Pain (VAS Score) Change in WOMAC Score Adverse Events (Safety Monitoring)
Participants are evaluated for change in pain intensity using the Visual Analog Scale (VAS). Best outcome: pain score significantly reduced. If any Worst outcome: no change or increased pain.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be used to assess pain, stiffness, and physical function. Best outcome: improved total WOMAC score.
Any local or systemic adverse events related to intra-articular administration of MSC secretome + PRP will be monitored and documented. Events will be categorized by type, severity, and relation to treatment.
Measured: From enrollment through the treatment period (Day 0 to Day 14); and at follow-up visits at 1 month, 3 months, 6 months, and 12 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start10 Dec 2025 (estimated)
- Primary completion11 Dec 2027 (estimated)
- Study completion11 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore.
- Responsible party
- Principal investigator, Noreen Latief, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157891
- Sponsor's protocol ID
- MSCSEC-OA-001
- Acronym
- PRGFSECKOA
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety and Regenerative Potential of MSC-Derived Secretome Combined With PRGF in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07157891
- Acronym / sponsor ID
- PRGFSECKOA / MSCSEC-OA-001
- Conditions
- Osteoarthritis (OA), Knee Injury, Cartilage Degeneration
- Keywords
- Mesenchymal Stem Cell Secretome, Plasma Rich in Growth Factors (PRGF), Platelet-Rich Plasma (PRP), Knee Osteoarthritis, Intra-articular Injection, Cell-free Therapy, Regenerative Medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Collaborators
- Centre of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore.
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 11 Dec 2027 (estimated)
- Study completion
- 11 Dec 2028 (estimated)
- First posted
- 5 Sep 2025 (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 Phase I/II randomized clinical trial investigates the safety, feasibility, and early regenerative potential of intra-articular administration of mesenchymal stem cell (MSC)-derived secretome combined with Plasma Rich in Growth Factors (PRGF) in patients with knee osteoarthritis (KOA). The study aims to assess whether this cell-free, biologically enriched therapeutic combination can reduce pain, improve joint function, and promote cartilage repair.
Detailed description
Osteoarthritis (OA) is a chronic, degenerative joint disease characterized by progressive cartilage degradation, joint space narrowing, subchondral bone remodeling, inflammation, and pain that ultimately impair mobility and quality of life. Current treatment options, including analgesics, corticosteroids, and surgery, offer symptomatic relief but do not halt disease progression or restore joint tissue integrity.
Recent advancements in regenerative medicine have highlighted the therapeutic potential of mesenchymal stem cells (MSCs), particularly adipose-derived MSCs (AD-MSCs) and umbilical cord- derived MSCs (UC-MSCs), due to their robust paracrine activity. Rather than relying solely on cell engraftment, MSCs exert their therapeutic effects primarily through their secretome. These are complex mixtures of cytokines, growth factors, extracellular vesicles (EVs), and exosomes. This secretome can promote cartilage repair, reduce inflammation, and modulate immune responses, all without the risks associated with live cell transplantation.
This prospective, interventional study aims to evaluate the safety, tolerability, and early efficacy of intra-articular administration of MSC-derived secretome combined with Plasma Rich in Growth Factors (PRGF) in patients with mild to moderate symptomatic knee osteoarthritis (Kellgren-Lawrence grade II-III).The secretome will be collected from culture of human ADMSCs and UCMSCs grown in GMP-compliant labs, characterized for sterility, protein content, particle size, and bioactivity prior to administration.
Primary outcomes will include pain reduction assessment and any adverse events via Visual Analog Scale (VAS) and WOMAC index. If there will be adverse events, they will also be checked. Secondary outcomes will include functional improvement, cartilage regeneration (X-ray or MRI assessment), and changes in synovial inflammatory biomarkers (e.g., IL-1β, TNF-α, IL-6, MMP-13).
This study hypothesizes that the cell-free combination of MSC secretome and PRGF will offer regenerative benefits in knee OA, potentially improving joint function and structure while minimizing the risks associated with live cell therapies. Findings from this trial will inform the design of future large-scale studies and support the development of secretome-based regenerative therapies for osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC-Derived Secretome | Experimental | Biological: MSC-Derived SecretomeMSC-derived secretome will be administered as intra-articular injections under ultrasound guidance to the affected knee. Injection will be given twice, each after 6 months. Each injection will consist of 2 mL of concentrated MSC-derived secretome. |
| MSC-Derived Secretome + Autologous PRGF | Experimental | Biological: MSC-Derived Secretome + Autologous PRGFMSC-derived secretome combined with autologous plasma-rich in growth factors plasma (PRGF) will be administered as intra-articular injections under ultrasound guidance to the affected knee. Injections will be given twice, each after 6 months. Each injection will consist of 2 mL of concentrated MSC-derived secretome and 1 mL of autologous PRGF, totaling 3 mL per dose. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Following is the inclusion criteria for the enrolment of patients affected with damaged cartilage in this study:
Key exclusion criteria (5 listed)
- • Secondary OA due to trauma, infection, rheumatoid arthritis, congenital disease or other inflammatory disorders of the knee
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 |
|---|---|---|
| MSC-Derived SecretomeAlso: Conditioned Medium, MSC Secretome TherapyThe secretome will be collected from cultured MSCs under sterile, GMP-compliant conditions and concentrated to retain bioactive molecules. It will be injected into the affected knee under ultrasound guidance. | Biological | MSC-Derived Secretome |
| MSC-Derived Secretome + Autologous PRGFAlso: MSC-Secretome/PRGF Combined TherapyMSC-derived secretome will be collected from mesenchymal stem cell cultures under sterile, GMP-compliant conditions. Autologous PRP will be prepared from the participant's own peripheral blood using a standardized single-spin centrifugation method and combined with 10% calcium chloride to activate growth factors. Both components will be mixed and administered into the affected joint under ultrasound guidance. | Biological | MSC-Derived Secretome + Autologous PRGF |
Primary outcome
Change in Knee Pain (VAS Score) Change in WOMAC Score Adverse Events (Safety Monitoring)
Time frame: From enrollment through the treatment period (Day 0 to Day 14); and at follow-up visits at 1 month, 3 months, 6 months, and 12 months post-treatment.
Participants are evaluated for change in pain intensity using the Visual Analog Scale (VAS). Best outcome: pain score significantly reduced. If any Worst outcome: no change or increased pain. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be used to assess pain, stiffness, and physical function. Best outcome: improved total WOMAC score. Any local or systemic adverse events related to intra-articular administration of MSC secretome + PRP will be monitored and documented. Events will be categorized by type, severity, and relation to treatment.
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 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MSC-Derived Secretome and MSC-Derived Secretome + Autologous PRGF in people with Osteoarthritis (OA) and Knee Injury, run by University of the Punjab.
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 8 inclusion and 5 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in Knee Pain (VAS Score) Change in WOMAC Score Adverse Events (Safety Monitoring) (time frame: From enrollment through the treatment period (Day 0 to Day 14); and at follow-up visits at 1 month, 3 months, 6 months, and 12 months post-treatment.). 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 5 Sep 2025.