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Phase I Safety Run In and Phase II Randomized Open Label, Blinded Endpoint Trial of Autologous Adipose Derived Mesenchymal Stromal Cells versus Hyaluronic Acid in Early Knee Osteoarthritis.

Phase I Safety Run In and Phase II Randomized Open Label, Blinded Endpoint Trial of Autologous Adipose Derived Mesenchymal Stromal Cells versus Hyaluronic Acid in Early Knee Osteoarthritis

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251020005
Enrollment
75
Registered
2025-10-20
Start date
2025-10-12
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physician-diagnosed early-stage knee osteoarthritis (Kellgren Lawrence grade II).Chronic knee pain persisting for a minimum of three months. A (WOMAC) pain subscale score more than 40 . early osteoarthritis

Interventions

Autologous adipose-derived stem cells 50M Cells in 3 ml,Hyaluronic Acid 2 ml
Osnozel,Hyaluronic Acid

Sponsors

Medeze Group PCL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 40 and 80 years. 2.Clinically diagnosed with early-stage osteoarthritis of the knee, specifically Kellgren-Lawrence (K-L) grade II, by a physician. 3.Presence of chronic knee pain for a minimum duration of 3 months. 4.Baseline WOMAC pain score greater than or equal to 40 (on a 0-100 scale). 5.Body Mass Index (BMI) less than 30 kg/m2. 6.Willingness to participate and provision of written informed consent. 7.Ability to comply with the scheduled follow-up visits. 8.General health status deemed suitable for study participation, as determined by the investigating physician. 9.Thai nationality, currently residing in Bangkok.

Exclusion criteria

Exclusion criteria: 1.History of knee surgery or receiving intra-articular injections within the preceding six months. 2.Diagnosis of other inflammatory or systemic arthropathies, such as rheumatoid arthritis (RA), gout, or Systemic Lupus Erythematosus (SLE). 3.Presence of septic arthritis or a prior history of joint infection. 4.Current use of anticoagulant medication that cannot be discontinued, or a pre-existing bleeding disorder. 5.Presence of any significant chronic systemic disease (comorbidities). 6.Pregnancy or lactation (breastfeeding). 7.Presence of a psychiatric disorder that compromises the ability to provide informed consent. 8.Participation in any other clinical trial within three months prior to enrollment. 9.Known allergy or hypersensitivity to the therapeutic agents (e.g., Hyaluronic Acid (HA)) or local anesthetics. 10.Considered unsuitable for participation by the investigator due to health or ethical concerns.

Design outcomes

Primary

MeasureTime frame
Osteoartritis 2 weeks, 1, 3, and 6 months. WOMAC Score

Secondary

MeasureTime frame
Pain 2 weeks, 1, 3, and 6 months. Visual Analog Scale,Knee injury or osteoarthritis 2 weeks, 1, 3, and 6 months. Knee injury and Osteoarthritis Outcome Score

Countries

Thailand

Contacts

Public ContactDr.Pornthep Tangkanchanavekul

Faculty of Medicine, Suranaree University of Technology

pornthep@sut.ac.th0815508353

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026