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

January 20, 2016 updated by: Phuc Van Pham, University of Science Ho Chi Minh City

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh, Vietnam
        • 115 Hospital, Ho Chi Minh city
      • Ho Chi Minh, Vietnam
        • Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
      • Ho Chi Minh, Vietnam
        • Van Hanh Hospital, Ho Chi Minh city, VN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Science Ho Chi Minh City

Collaborators

Van Hanh General Hospital
GeneWorld Co., Ltd., Ho Chi Minh
115 People's Hospital

Investigators

  • Study Director: Phuc V Pham, PhD, Laboratory of Stem Cell Research and Application, University of Science, VNU-HCM, VN
  • Principal Investigator: Phuong TB Le, MSc, MD, Van Hanh Hospital, Ho Chi Minh city, VN
  • Principal Investigator: Phu D Nguyen, PhD, MD, 115 Hospital, HCM
  • Principal Investigator: Ho H La, MD, Van Hanh Hospital, Ho Chi Minh city, VN
  • Principal Investigator: Tung DX Tran, MSc, MD, Van Hanh Hospital, Ho Chi Minh city, VN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1438/QDBYT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Autologous adipose tissue stromal vascular fraction and platelet rich plasma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe