Allogenic mesenchymal stem cell intraarticular injection for knee osteoarthritis therapy, an RCT explorative mode-of-action study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aarhus University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

7 Mar 2024 → ongoing

Decision date (initial)

2024-02-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Innovation fund denmark · The Danish Rheumatism Association · Steno diabetes center Aarhus

External identifiers

EU CT number

2023-506088-33-01

ClinicalTrials.gov

NCT05933434

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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

Secondary objectives 3

1. To objectively evaluate whether AD-MSC treatment leads to cartilage regeneration on MRI (MRI Osteoarthritis Knee Score and Quantitative MRI protocol
2. To evaluate whether AD-MSC treatment leads to pain reduction on a NRS scale
3. To objectively evaluate whether AD-MSC treatment leads to improvement in function and clinical signs based on clinical examination (Range of motion, Effusion tests (swelling), Knee diameter on the patellae (swelling), Atrophy (measure quadriceps muscle bulk 10 cm above the patellae top)

Conditions and MedDRA coding

knee osteoarthritis

Study design 1 period

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 17

1. Donor
2. 1. Male or female aged 18-50 years
3. 2. Planned cosmetic operation of excessive fat of abdominal, flank, arm and thigh fat
4. 3. BMI 18,5-30
5. 4. Non-smokers (defined as smoking cessation >12 weeks)
6. 5. Operation of at least 30 mL adipose tissue
7. 6. Speaks Danish
8. 7. Legally competent and able to sign the written consent
9. Patient
10. 1. Male or female aged 40 to <75 years
11. 2. Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)
12. 3. Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.
13. 4. Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity
14. 5. Medial, lateral or dual compartment OA as determined above
15. 6. BMI <35
16. 7. Danish speaker
17. 8. Patients must be legally competent and must be able to sign the written consent

Exclusion criteria 23

1. Donor
2. 1. Age >50 years
3. 2. BMI >30 or <18,4
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
5. 4. Taking immunosuppressive/immunomodulating medication
6. 5. Breastfeeding
7. 6. Cognitive impairment
8. 7. Active smoker
9. Patient
10. 1. Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
11. 2. Intraarticular tumor, infection or fracture
12. 3. Pregnancy and breast feeding
13. 4. Cognitive impairment
14. 5. Treatment with cytostatic drugs
15. 6. Previous intraarticular knee injection in the past 3 mo.
16. 7. Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity (>BMI 35)
17. 8. Previous ligament reconstruction
18. 9. Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)
19. 10. Knee instability on physical examination
20. 11. History of allergy to antibiotics
21. 12. Diabetes mellitus type 1 or dysregulated type 2 diabetes
22. 13. Concomitant severe infection, malignant tumor, coagulation diseases, autoimmune disease or uncontrolled or unmanaged systemic disease
23. 14. Presence of other types of inflammatory arthritis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Knee symptoms as evaluated by the Knee Injury and Osteoarthritis Score (KOOS)
2. Pain diary (first 30 days after AD-MSC or placebo treatment), Adverse events will be collected the first year after AD-MSC or placebo treatment

Secondary endpoints 3

1. Cartilage regeneration (MRI Osteoarthritis Knee Score), Quantitative MRI protocol
2. Pain as reported on the Numeric Rating Scale (NRS)
3. Range of motion, Effusion tests (swelling), Knee diameter on the patellae (swelling), Atrophy (measure quadriceps muscle bulk 10 cm above the patellae top)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aarhus University

Sponsor organisation

Aarhus University

Address

Vennelyst Boulevard 4

City

Aarhus C

Postcode

8000

Country

Denmark

Scientific contact point

Organisation

Aarhus University

Contact name

Michael Pedersen

Public contact point

Organisation

Aarhus University

Contact name

Michael Pedersen

Third parties 2

Sponsor responsibilities

Article 77 compliance

Aarhus University

Contact point sponsor

Aarhus University

Article 77 implementation

Aarhus University

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications