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A Single Intra-articular Injection of aMAT vs PRP in Patients With OA of the Knee

NCT03117608 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2017-08-29

No results posted yet for this study

Summary

The study proposes to compare performances and safety of intra-articular injections of aMAT with those of a control group (PRP injections) for the treatment of symptomatic OA of the knee. The end-points will be determined evaluating the performances of the treatment group in terms of improvement of the symptomatology, functional recovery and radiological appearance.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

injection of autologous micro-fragmented adipose tissue (aMAT)

adipose tissue will be obtained from abdominal region or buttocks and aMAT, and processed with Lipogems® technology.

BIOLOGICAL

injection of Platelet-rich Plasma (PRP)

injection of platelet-rich plasma

Sponsors & Collaborators

  • Lipogems International spa

    lead INDUSTRY

Principal Investigators

  • Silvia Versari · Lipogems International spa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-24
Primary Completion
2022-08-24
Completion
2024-02-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03117608 on ClinicalTrials.gov