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

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

Vietnam

Study Type

Interventional

Intervention

Autologous adipose tissue stromal vascular fraction and platelet rich plasma

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Adipose stem cell, Platelet rich plasma, Knee Osteoarthritis, Injured cartilage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

Change from the baseline pain score (VAS) at 6 months

Change from baseline Lysholm score at 6 months

Change from baseline MRI assessment

Full Information

NCT ID

NCT02142842

First Posted

May 16, 2014

Last Updated

January 20, 2016

Sponsor

University of Science Ho Chi Minh City

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02142842

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Science Ho Chi Minh City

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Autologous adipose tissue stromal vascular fraction and platelet rich plasma

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change from the baseline pain score (VAS) at 6 months

Time Frame

6 months, 12 months, 18 months

Title

Change from baseline Lysholm score at 6 months

Time Frame

6 months, 12 months, 18 months

Title

Change from baseline MRI assessment

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: