The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-10

Study Completion Date

2020-12-05

Brief Summary

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Osteoarthritis of the knee is one of the most common causes of disability among elderly. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow Mesenchymal Stem Cells (MSC) and stromal Vascular Fraction (SVF) in patients with severe knee osteoarthritis

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Detailed Description

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This is single center, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. All subjects will undergo bone marrow aspiration. Mesenchymal Stem Cells will be isolated from bone marrow and stromal Vascular Fraction fram lipoaspirate, cultured and transplanted back to the knee joint. Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo will be administered in this group 6 months after the first injection. Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed before and 6 months after the first injection by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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mesenchymal stem cell

Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection

Group Type EXPERIMENTAL

Mesenchymal stem cell

Intervention Type BIOLOGICAL

intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation

placebo

The patients who are in control group and underwent placebo injection

Group Type EXPERIMENTAL

Placebo

Intervention Type BIOLOGICAL

Patients with knee joint osteoarthritis who underwent intra articular placebo injection

Interventions

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Mesenchymal stem cell

intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation

Intervention Type BIOLOGICAL

Placebo

Patients with knee joint osteoarthritis who underwent intra articular placebo injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis diagnosed by MRI

Exclusion Criteria

* Pregnancy or lactating
* Positive tests for HIV, Hepatitis C virus (HCV), Hepatitis C virus (HBV)
* Active neurologic disorder
* End organ damage
* Uncontrolled endocrine disorder

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No