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

Phase 1

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Biological: Autologous adipose tissue stromal vascular fraction and platelet rich plasma

• Registration Number: NCT02142842
• Lead Sponsor: University of Science Ho Chi Minh City

Brief Summary

Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.

Detailed Description

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).

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-20
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Autologous adipose tissue stromal vascular fraction and platelet rich plasma	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	6 months

Secondary Outcome Measures

Name	Time	Method
Change from the baseline pain score (VAS) at 6 months	6 months, 12 months, 18 months
Change from baseline MRI assessment	12 months
Change from baseline Lysholm score at 6 months	6 months, 12 months, 18 months

Trial Locations

Locations (3)

Van Hanh Hospital, Ho Chi Minh city, VN; 🇻🇳 Ho Chi Minh, Vietnam

Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh; 🇻🇳 Ho Chi Minh, Vietnam

115 Hospital, Ho Chi Minh city; 🇻🇳 Ho Chi Minh, Vietnam