Clinical trial NCT03869229: Adipose-derived Mesenchymal Stem Cells in Osteoarthritis
Official title: Effectiveness of Adipose-derived Mesenchymal Stem Cells in Patients With Osteoarthritis of the Knee, Hip or Glenohumeral Joint and Analysis of the Regeneration Processes Based on Inflammatory Markers, microRNAs and Clinical Features.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Glenohumeral Osteoarthritis
Osteoarthritis
Keywords: osteoarthritis
Adipose-derived Mesenchymal Stem Cells
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/glenohumeral joints will be enrolled according to strict inclusion and exclusion criteria. Subjects will receive a single dose of at least 10 million of autologous Adipose-derived Mesenchymal Stem Cells (ADMCS) every three months for 12 months (maximum four doses in total and at least 40 million of ADMCS in total) via ultrasound guided intra-articular injection.

Detailed description: This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. All patients will be selected and sign consent forms, then divided into 3 groups based on clinical presentation. Participants will be exposed to abdominal liposuction procedure under local anesthesia for adipose-derived mesenchymal stem cells (ADMSC) harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated in the Polish Stem Cell Bank. The activated stem cells will be injected into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be performed under ultrasound guidance at the theater under spinal anesthesia. Each patient will receive a single dose of at least 10 million of ADMSC in 3 mL of normal saline every three months for 12 months (maximum four doses in total and at least 40 million of ADMSC in total) via ultrasound guided intra-articular injection. During the study period and 24 months after last injection they will be followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected joint. The local and systemic safety of the procedure and therapy with ADMSC will be also determined during study.

Eligibility criteria: Inclusion Criteria:

* presence of osteoarthritis of the knee, hip or glenohumeral joint
* confirmation cartilage injury, articular cartilage part or full-thickness injury by MR (Magnetic Resonance)
* joint pain of VAS (visual analog scale score) is 1 or higher while resting, 2 and higher during any physical activity
* loss of joint function based on scale specific for certain joints; for hip: HHS scale (Harris Hip Score), HOOS scale (Hip disability and Osteoarthritis Outcome Score), The Western Ontario and McMaster Universities Arthritis Index (WOMAC); for knee: modified HHS score (Harris Hip Score), The Western Ontario and McMaster Universities Arthritis Index (WOMAC), The International Knee Documentation Committee (IKDC Questionnaire) and KOOS scale (Osteoarthritis Outcome Score); glenohumeral joint: Disability of Arm, Shoulder and Hand \[DASH\], CONSTANT score
* clinical indication for surgical intervention
* no effect of pharmacotherapy according to The World Health Organization (WHO) analgesic ladder lasting at least 6 months
* no effect of physical rehabilitation lasting at least 6 months
* willing to participate understand and sign the consent form of this study

Exclusion Criteria:

* active inflammatory disease or infection,
* skin disease/infection around joint,
* severe heart failure,
* anemia,
* active/history of human immunodeficiency viruses (HIV), the hepatitis B virus (HBV) or the hepatitis C virus (HCV) infection,
* pregnant or breast-feeding women,
* mental disease, addiction to drugs or alcohol,
* participate other clinical experiments in 6 months,
* refuse to sign the consent form, or cannot keep follow-up visit.

Primary outcomes:
measure: HIP DISABILITY AND OSTEOARTHRITIS OUTCOME SCORE (HOOS)
timeFrame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: Harris Hip Score
timeFrame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: modified Harris Hip Score for knee
timeFrame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: The International Knee Documentation Committee (IKDC Questionnaire)
timeFrame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: WOMAC (for hip and knee)
timeFrame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: Disability of Arm, Shoulder and Hand [DASH]
timeFrame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: The Constant-Murley score (CMS)
timeFrame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: Visual Analog Scale (VAS)
timeFrame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
Secondary outcomes:
measure: Nature, incidence and severity of adverse events (AEs)
timeFrame: Time Frame: Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
measure: Change in cartilage thickness
timeFrame: Baseline, and 12 months post-treatment cycle
measure: Change in cartilage volume
timeFrame: Baseline, and 12 months post-treatment cycle
measure: Change in cartilage morphology
timeFrame: Baseline, and 12 months post-treatment cycle
measure: Change in subchondral bone morphology
timeFrame: Baseline, and 12 months post-treatment cycle
measure: Inflammation monitoring
timeFrame: Baseline, and 12 months post-treatment cycle]
measure: Inflammation monitoring
timeFrame: Baseline, and 12 months post-treatment cycle
measure: Inflammation monitoring
timeFrame: Baseline, and 12 months post-treatment cycle
measure: Inflammation monitoring
timeFrame: Baseline, and 12 months post-treatment cycle
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Life Clinic
state: Mazovian
Study officials:
affiliation: Medical University of Warsaw
name: Marek Postula, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Life Clinic
name: Robert Smiegielski, MD
role: STUDY_DIRECTOR
References: