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Allogenic mesenchymal stem cell intraarticular injection for knee osteoarthritis therapy, an RCT explorative mode-of-action study
EU CTIS ID: 2023-506088-33-00
What this study is testing
To assess the safety and clinical efficiency (knee symptoms) of intraarticular knee injection of adipose derived mesenchymal stem cells compared to intraarticular knee placebo injection
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Donor
- 1. Male or female aged 40 to <75 years
- 2. Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)
- 3. Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.
- 4. Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity
- 5. Medial, lateral or dual compartment OA as determined above
You likely can't join if
- Donor
- 1. Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
- 2. Intraarticular tumor, infection or fracture
- 3. Pregnancy and breast feeding
- 4. Cognitive impairment
- 5. Treatment with cytostatic drugs
See the full eligibility criteria
- Donor
- 1. Male or female aged 40 to <75 years
- 2. Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)
- 3. Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.
- 4. Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity
- 5. Medial, lateral or dual compartment OA as determined above
- 6. BMI <35
- 7. Danish speaker
- 8. Patients must be legally competent and must be able to sign the written consent
- 1. Male or female aged 18-50 years
- 2. Planned cosmetic operation of excessive fat of abdominal, flank, arm and thigh fat
- 3. BMI 18,5-30
- 4. Non-smokers (defined as smoking cessation >12 weeks)
- 5. Operation of at least 30 mL adipose tissue
- 6. Speaks Danish
- 7. Legally competent and able to sign the written consent
- Patient
- Donor
- 1. Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
- 2. Intraarticular tumor, infection or fracture
- 3. Pregnancy and breast feeding
- 4. Cognitive impairment
- 5. Treatment with cytostatic drugs
- 6. Previous intraarticular knee injection in the past 3 mo.
- 7. Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity (>BMI 35)
- 8. Previous ligament reconstruction
- 9. Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)
- 10. Knee instability on physical examination
- 1. Age >50 years
- 11. History of allergy to antibiotics
- 12. Diabetes mellitus type 1 or dysregulated type 2 diabetes
- 13. Concomitant severe infection, malignant tumor, coagulation diseases, autoimmune disease or uncontrolled or unmanaged systemic disease
- 14. Presence of other types of inflammatory arthritis
- 2. BMI >30 or <18,4
- 3. Known comorbidities: diabetes mellitus Type I and II, infectious diseases (HIV, hepatitis B, hepatitis C or syphilis), cancer, autoimmune disorders, metabolic diseases (hyper and hypothyreosis), metabolic syndrome
- 4. Taking immunosuppressive/immunomodulating medication
- 5. Breastfeeding
- 6. Cognitive impairment
- 7. Active smoker
- Patient
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.