Autologous Adipose Stem Cells and Platelet Rich Plasma Therapy for Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.

Detailed Description
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The proposed study is two centers, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) in combination with platelet rich plasma (PRP). This study aimes to evaluate the clinical efficiency of autologous adipose tissue-derived MSC transplantation in patients with confirmed osteoarthritis at grade II and III. Adipose tissue is isolated from the belly, and used for extraction of the SVF. The SVF is mixed with activated platelet-rich plasma before injection. The clinical efficiencies are evaluated by the pain score (VAS), Lysholm score, and MRI findings. SVF is isolated from about 100 mL of adipose tissue, and PRP is prepared from 20 mL of peripheral blood. Total injection volume will be about 5-10 mL. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).

Official Title
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Phase I/II Study of Transplantation of Autologous Adipose Stem Cells and Activated Platelet Rich Plasma in Knee Osteoarthritis Treatment

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Biological: Autologous adipose tissue stromal vascular fraction and platelet rich plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years and ability to understand the planned treatment. Idiopathic or secondary osteoarthritis of the knee with grade 2, 3 radiographic severity Ability and willingness to undergo liposuction Exclusion Criteria: Pregnant women or cognitively impaired adults. Presence of large meniscal tears (bucket handle tears), as detected by clinical examination or by magnetic resonance imaging. Inflammatory or postinfectious arthritis. More than 5 degrees of varus or valgus deformity. Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age. Intraarticular corticosteroid injection within the previous 3 months. A major neurologic deficit. Serious medical illness with a life expectancy of less than 1 year. Prior admission for substance abuse Body Mass Index (BMI) of 40 kg/m2 or greater Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be injected into joints of 16 patients with grade 2, 3 radiographic OA severity with 16 patients as control. | Biological: Autologous adipose tissue stromal vascular fraction and platelet rich plasma<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the baseline pain score (VAS) at 6 months |  | 6 months, 12 months, 18 months | 
| Change from baseline Lysholm score at 6 months |  | 6 months, 12 months, 18 months | 
| Change from baseline MRI assessment |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adipose stem cell, Platelet rich plasma, Knee Osteoarthritis, Injured cartilage