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

April 15, 2026 updated by: Cellcolabs Clinical SPV Limited
StromaForte injection for knee OA

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: StromaForte- Mesenchymal Stem cells
Human Allogenic Bone marrow derived Mesenchymal Stem cells
Other: Mesenchymal Stem Cells (MSC)
StromaForte
Active Comparator: Hyaluronic Acid
Other: Hyaluronic Acid (HA)
Hyaluronic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
"From enrollment to the end of follow-up at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
From enrollment to the end of follow-up at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellcolabs Clinical SPV Limited

Investigators

  • Study Director: Ola Jeppsson, Cellcolabs Clinical SPV Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 27, 2026

Primary Completion (Estimated)

September 27, 2027

Study Completion (Estimated)

September 27, 2027

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-002-ARE
  • RCMOHP/CT2/0914/2025/251125 (Other Identifier: Ministry of Health / Emirates Drug Establishment)
  • DOH/ADHRTC/2025/1599 (Other Identifier: Department of Health / AbuDhabi)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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