A phase 2b Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients with Knee Osteoarthritis

Phase 2

Completed

• Conditions: damaged cartilage; Knee arthrosis; 10023213

• Registration Number: NL-OMON47160
• Lead Sponsor: CHRU Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1) Male or female between the ages of 45 and 70, during screening.
2) BMI between 20 and 35 kg/m2
3) Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined at baseline by the American college of Rheumatology (ACR):
-History of pain in the index knee * 6 months, AND
-Kellgren and Lawrence (K-L) Grade 2 or 3 only, on plain radiographs of the index knee (including fixed flexion), AND
-Swelling of the index knee evaluated by the investigator
4) Must meet the following pain criteria at the time of baseline visit since at least half of the days in the previous month:
-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscores * 40 mm on the 0-100 normalised scale
-Visual analogis scale (VAS) pain rating of at least 40 on a 100-mm scale
-Subject*s global assessment of arthritis status must be fair, poor, or very poor
-Subject*s global assessment of the contralateral knee <20 mm by 100-mm using VAS*
5) NSAID washout of at least 2 days before screening and baseline
6) Written informed consent dated and signed prior to the beginning of any procedures related to the clinical trial

Exclusion Criteria

1) Previous treatments acting on cartilage or bone metabolism (eg, oral or intravenous bisphosphonates <1 year previously, strontium ranelate or teriparatide or raloxifene <7 days prior to selection, and oral glucosamine *1500 mg/day and chondroitin sulphate <3 months previously)
2) Has had any trauma of the index knee in the previous 12 months prior to the screening visit
3) Has OA of the index knee that meets K-L classification criteria of grade 1 or 4
4) Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, back, or contralateral knee (* 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
5) Prior to the screening visit, has received:
-Oral corticosteroid therapy within the previous 3 month, OR
-Intramuscular, intravenous or epidural corticosteroid therapy within the previous 6 months, OR
-Intra-articular injection of corticosteroids in the index within the previous 6 months, OR
-Intra-articular injection of hyaluronic acid in the index knee within the 6 months. OR
-Intra-articular injection of platelet rich plasma in the index knee within the 6 months.
-Tramadol or Opioids (alone or in combination products) therapy within the previous month
6) Inflammatory or other rheumatic diseases defined by clinical examination and previous serum markers (such as rheumatoid arthritis, autoimmune disorder, seronegative spondyloarthritis, gout or pseudogout (defined as acute episodic attacks of swollen, painful joint in a patient with X-ray chondrocalcinosis or CPPD crystals))
7) Severe misalignment of the knee (excessive varus or valgus * 8°) at physical examination, as confirmed by standard radiograph
8) Severe osteoporosis with previous fractures
9) History of joint replacement of the knee or hip within the previous 12 months
10) Serious systemic diseases or infectious/inflammatory skin diseases in the area of the affected knee
11) Positive serology for HIV, hepatitis B, C and syphilis
12) History of cancer or blood dyscrasias, or previous chemotherapy, radiotherapy or immunotherapy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Efficacy Analysis:<br /><br>* Improvement from baseline to month 6 in WOMAC pain score of the index knee.<br /><br>* Improvement from baseline to month 6 in WOMAC physical function score of the<br /><br>index knee.<br /><br><br /><br>The main objective is to evaluate the efficacy of a single intra-articular<br /><br>injection of ASC (either 2.106 or 10.106 ASC) in mild to moderate knee OA (KL<br /><br>2-3) based on improvement of WOMAC pain and function subscore at 6 month,<br /><br>compared to placebo (vehicle: 0.5% glucose in saline with 4,5% human albumin)..</p><br>