Knee Arthritis OsteoarthritisPhase 2/3NCT07542808
An Open-Label, Double-Treatment Group Study to Evaluate the Efficacy and Safety of Human Allogeneic Bone-Marrow- Derived Mesenchymal Stromal Cell Product StromaForte Compared With Hyaluronic Acid for the Treatment of Knee Osteoarthritis
A Phase 2/3 study testing Mesenchymal Stem Cells (MSC) and Hyaluronic Acid (HA) in people with Knee Arthritis Osteoarthritis, run by Cellcolabs Clinical SPV Limited at 1 site in United Arab Emirates.
Trial summary
StromaForte injection for knee OA Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthritis Osteoarthritis
- What is being tested?
- Mesenchymal Stem Cells (MSC) and Hyaluronic Acid (HA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 27 Apr 2026to 27 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent and comply with all procedures required by the protocol.
- Aged ≥ 18 years at the time of signing the informed consent form.
- Diagnosed with knee osteoarthritis (OA) based on the criteria established by the American College of Rheumatology, confirmed through radiological images no older than three months.
- Grade I to IV osteoarthritis on the Kellgren-Lawrence radiological classification scale.
- Joint pain during activity as assessed by the Visual Analogue Scale (VAS) of ≥ 40 at the time of screening
- Body Mass Index (BMI) between ≥ 18.5 to ≤ 35.0 kg/m2
Who cannot join
- Unwilling or unable to perform any of the assessments required by the protocol.
- Mechanically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear.
- Varus or valgus malalignment >5 degrees as measured by 4-foot standing antero-posterior radiographs.
- History of subtotal medial or lateral meniscectomy performed less than 9 months ago.
- History of septic arthritis in the targeted knee.
- History of infectious or inflammatory joint disorders or suspected infective or inflammatory joint disease.
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- Systemic or intra-articular injection of corticosteroids in any joint within 3 months before screening.
- Immunosuppression due to illness or medication including but not limited to high dose corticosteroids, calcineurin inhibitors, anti-TNF, anti-IL-6, anti-p40, biologics and prednisone and/or equivalent over 5 mg/day.
- Planned orthopaedic surgery on lower limbs within the next 12 months
- Active or suspected infection.
- History of malignancy in the past 2.5 years, except in-situ cancers treated by local excision with curative intent.
- Severe bleeding diathesis.
- Participation in another clinical trial including treatment with a different investigational product within 30 days prior to inclusion in this study.
- Pregnancy or breastfeeding.
- Unwilling or for medical reason not recommended to pause anticoagulant medications prior to procedure, as judged by prescribing doctor.
- Known diagnosis of HIV-1, HIV-2, Hepatitis A, Hepatitis B, Hepatitis C, HTLV-I/II, or Syphilis, or other acute or chronic infectious disease.
- Pulmonary embolism, deep vein thrombosis or other serious embolic disease within the past 4 months.
- Known allergies or hypersensitivity to DMSO, human serum albumin, heparin or PlasmaLyte.
- History or current evidence of any condition, therapy, laboratory abn ormality, or other circumstance that might confound the results of the study or interfere with the study participant's participation for the full duration of the study.
- Cognitive or language barriers that prohibit obtaining informed consent, questionnaires or any study elements.
- Recipient of any stem cell therapy within the previous 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Burjeel Medical City
Abu Dhabi
Rana Damees, +971505347439, rana.damsees@burjeelholdings.com
About this study
StromaForte injection for knee OA
- Conditions
- Knee Arthritis Osteoarthritis
- Being tested
- Mesenchymal Stem Cells (MSC), Hyaluronic Acid (HA)
- Keywords
- Cellcolabs, Knee OA, Mesenchymal stem cells, Cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cells (MSC)Other
StromaForte
Hyaluronic Acid (HA)Other
Hyaluronic Acid
| Study group | Role | What they receive |
|---|---|---|
| StromaForte- Mesenchymal Stem cells | Experimental | Human Allogenic Bone marrow derived Mesenchymal Stem cells Receives: Other: Mesenchymal Stem Cells (MSC) |
| Hyaluronic Acid | Active comparator | Hyaluronic Acid Receives: Other: Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To show that StromaForte single dose treatment provides superior pain reduction from baseline to 6 months post-injection compared to hyaluronic acid single dose treatment.
Change from baseline in subjective pain during activity assessment according to the Visual Analogue Scale (VAS) questionnaire at 6 months ±30 days post-injection.
Measured: "From enrollment to the end of follow-up at 1 year
Secondary outcomes (2)
To evaluate the effect of StromaForte single dose treatment on pain reduction from baseline to 3 months and 12 months post-injection, compared to hyaluronic acid single dose treatment.
Change from baseline in subjective pain during activity assessment according to the Visual Analogue Scale (VAS) questionnaire at 3 months ±30 days and 12 months ±30 days post-injection.
Measured: From enrollment to the end of follow-up at 1 year
To evaluate the effect of StromaForte single dose treatment on improvement of the patient's functional ability at 3 months, 6 months and 12months post-injection, compared to hyaluronic acid single dose treatment.
Change in functional ability using the Knee injury and Osteoarthritis Outcome Score (KOOS) scores from baseline to 3 months ±30 days, 6 months ±30 days and 12 months±30 days post-injection.
Measured: From enrollment to the end of follow-up at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start27 Apr 2026 (estimated)
- Primary completion27 Sep 2027 (estimated)
- Study completion27 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis OsteoarthritisStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellcolabs Clinical SPV Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ola Jeppsson, Study director, Cellcolabs Clinical SPV Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542808
- Sponsor's protocol ID
- 2024-002-ARE
- Other IDs
- RCMOHP/CT2/0914/2025/251125, DOH/ADHRTC/2025/1599
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Double-Treatment Group Study to Evaluate the Efficacy and Safety of Human Allogeneic Bone-Marrow- Derived Mesenchymal Stromal Cell Product StromaForte Compared With Hyaluronic Acid for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07542808
- Acronym / sponsor ID
- 2024-002-ARE
- Conditions
- Knee Arthritis Osteoarthritis
- Keywords
- Cellcolabs, Knee OA, Mesenchymal stem cells, Cell therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cellcolabs Clinical SPV LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2026 (estimated)
- Primary completion
- 27 Sep 2027 (estimated)
- Study completion
- 27 Sep 2027 (estimated)
- First posted
- 21 Apr 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.
StromaForte injection for knee OA
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StromaForte- Mesenchymal Stem cells | Experimental | Other: Mesenchymal Stem Cells (MSC)Human Allogenic Bone marrow derived Mesenchymal Stem cells |
| Hyaluronic Acid | Active comparator | Other: Hyaluronic Acid (HA)Hyaluronic Acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide written informed consent and comply with all procedures required by the protocol.
- Aged ≥ 18 years at the time of signing the informed consent form.
- Diagnosed with knee osteoarthritis (OA) based on the criteria established by the American College of Rheumatology, confirmed through radiological images no older than three months.
- Grade I to IV osteoarthritis on the Kellgren-Lawrence radiological classification scale.
- Joint pain during activity as assessed by the Visual Analogue Scale (VAS) of ≥ 40 at the time of screening
Key exclusion criteria (21 listed)
- Unwilling or unable to perform any of the assessments required by the protocol.
- Mechanically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear.
- Varus or valgus malalignment >5 degrees as measured by 4-foot standing antero-posterior radiographs.
- History of subtotal medial or lateral meniscectomy performed less than 9 months ago.
- History of septic arthritis in the targeted 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 |
|---|---|---|
| Mesenchymal Stem Cells (MSC)StromaForte | Other | StromaForte- Mesenchymal Stem cells |
| Hyaluronic Acid (HA)Hyaluronic Acid | Other | Hyaluronic Acid |
Primary outcome
To show that StromaForte single dose treatment provides superior pain reduction from baseline to 6 months post-injection compared to hyaluronic acid single dose treatment.
Time frame: "From enrollment to the end of follow-up at 1 year
Change from baseline in subjective pain during activity assessment according to the Visual Analogue Scale (VAS) questionnaire at 6 months ±30 days post-injection.
2 secondary outcomes
To evaluate the effect of StromaForte single dose treatment on pain reduction from baseline to 3 months and 12 months post-injection, compared to hyaluronic acid single dose treatment.
Time frame: From enrollment to the end of follow-up at 1 year
To evaluate the effect of StromaForte single dose treatment on improvement of the patient's functional ability at 3 months, 6 months and 12months post-injection, compared to hyaluronic acid single dose treatment.
Time frame: From enrollment to the end of follow-up at 1 year
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 21 Apr 2026.
- 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.
Ola Jeppsson study director
Cellcolabs Clinical SPV Limited
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 Mesenchymal Stem Cells (MSC) and Hyaluronic Acid (HA) in people with Knee Arthritis Osteoarthritis, run by Cellcolabs Clinical SPV Limited at 1 site in United Arab Emirates.
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 21 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: looking for participants now, as of the sponsor's last update on 21 Apr 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 United Arab Emirates. 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 Bahar Kasaei (+971506845410, hello@cellcolabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To show that StromaForte single dose treatment provides superior pain reduction from baseline to 6 months post-injection compared to hyaluronic acid single dose treatment. (time frame: "From enrollment to the end of follow-up at 1 year). 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 21 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.