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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02142842

Enrollment

Registered

2014-05-20

Start date

2013-04-30

Completion date

2015-12-31

Last updated

2016-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Adipose stem cell, Platelet rich plasma, Knee Osteoarthritis, Injured cartilage

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).

Interventions

BIOLOGICALAutologous adipose tissue stromal vascular fraction and platelet rich plasma

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events	6 months

Secondary

Measure	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

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026