Adipose-derived Mesenchymal Stem Cells in Osteoarthritis

Medical University of Warsaw

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Osteoarthritis; Glenohumeral Osteoarthritis; Hip Osteoarthritis; Knee Osteoarthritis

Treatments: Biological: Intra-articular injection of ADMSC

Study type: Interventional

Funder types: Other

Identifiers

NCT03869229

002/LIFE/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

osteoarthritis of the knee

Active Comparator group

Description:

Intervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)

Treatment:

Biological: Intra-articular injection of ADMSC

osteoarthritis of the hip

Active Comparator group

Description:

Intervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)

Treatment:

Biological: Intra-articular injection of ADMSC

osteoarthritis of the glenohumeral joint

Active Comparator group

Description:

Intervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)

Treatment:

Biological: Intra-articular injection of ADMSC