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New treatment option for Knee Osteoarthritis
Official title Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
ClinicalTrials.gov ID: NCT05933434
What this study is testing
What is Allogenic adipose derived mesenchymal stem cells (AD-MSC)?
Allogenic adipose derived mesenchymal stem cells (AD-MSC) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for knee osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I and II double blinded randomized clinical controlled trial investigates the safety and efficacy of intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC), in patients suffering from mild-moderate knee osteoarthritis compared to placebo injection with saline.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)
- Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.
- Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity
- Medial, lateral or dual compartment OA as determined above
- BMI \<35
You likely can't join if
- Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
- Intraarticular tumor, infection or fracture
- Pregnancy and breast feeding
- Cognitive impairment
- Treatment with cytostatic drugs
- Previous intraarticular knee injection in the past 3 mo.
See the full eligibility criteria
- Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)
- Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.
- Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity
- Medial, lateral or dual compartment OA as determined above
- BMI \<35
- Danish speaker
- Patients must be legally competent and must be able to sign the written consent
- Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
- Intraarticular tumor, infection or fracture
- Pregnancy and breast feeding
- Cognitive impairment
- Treatment with cytostatic drugs
- Previous intraarticular knee injection in the past 3 mo.
- Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity(\>BMI 35)
- Previous ligament reconstruction
- Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)
- Diabetes mellitus type 1 and 2
- Knee instability on physical examination
- History of allergy to antibiotics
- Concomitant severe infection, malignant tumor, coagulation diseases or uncontrolled or unmanaged systemic disease
- Presence of other types of inflammatory arthritis
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.