Adipose-derived Mesenchymal Stem Cells in Osteoarthritis

NCT ID: NCT03869229

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-05
• Study Completion Date: 2022-03-20

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.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis; Glenohumeral Osteoarthritis; Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

osteoarthritis of the knee

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

Group Type: ACTIVE_COMPARATOR

Intra-articular injection of ADMSC

Intervention Type: BIOLOGICAL

Intervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)- ultrasound guided intra-articular injection of at least 10 million of ADMCS per procedure, maximum four procedures (i.e. injections per joint), minimum number of cells pre protocol 40 million

osteoarthritis of the hip

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

Group Type: ACTIVE_COMPARATOR

Intra-articular injection of ADMSC

Intervention Type: BIOLOGICAL

Intervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)- ultrasound guided intra-articular injection of at least 10 million of ADMCS per procedure, maximum four procedures (i.e. injections per joint), minimum number of cells pre protocol 40 million

osteoarthritis of the glenohumeral joint

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

Group Type: ACTIVE_COMPARATOR

Intra-articular injection of ADMSC

Intervention Type: BIOLOGICAL

Intervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)- ultrasound guided intra-articular injection of at least 10 million of ADMCS per procedure, maximum four procedures (i.e. injections per joint), minimum number of cells pre protocol 40 million

Interventions

Intra-articular injection of ADMSC

Intervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)- ultrasound guided intra-articular injection of at least 10 million of ADMCS per procedure, maximum four procedures (i.e. injections per joint), minimum number of cells pre protocol 40 million

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marek Postula, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Robert Smiegielski, MD

Role: STUDY_DIRECTOR

Life Clinic

Locations

Life Clinic

Warsaw, Mazovian, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Marek Postula, MD, PhD

Role: CONTACT

mpostula@wum.edu.pl

+48605113346

Robert Śmigielski, MD, PhD

Role: CONTACT

rsmigielski@gmail.com

+48609455055

Facility Contacts

Robert Śmigielski, MD

Role: primary

+48609455055

Robert Śmigielski

Role: backup

Other Identifiers

002/LIFE/2019

Identifier Type: -

Identifier Source: org_study_id