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

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ClinicalTrials.gov Identifier: NCT02142842
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : January 22, 2016
Sponsor:
Collaborators:
GeneWorld Co., Ltd., Ho Chi Minh
Van Hanh General Hospital
115 People's Hospital, Ho Chi Minh City
Information provided by (Responsible Party):
Phuc Van Pham, University of Science Ho Chi Minh City

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

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Autologous adipose tissue stromal vascular fraction and platelet rich plasma Phase 1 Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Transplantation of Autologous Adipose Stem Cells and Activated Platelet Rich Plasma in Knee Osteoarthritis Treatment
Study Start Date : April 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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



Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from the baseline pain score (VAS) at 6 months [ Time Frame: 6 months, 12 months, 18 months ]
  2. Change from baseline Lysholm score at 6 months [ Time Frame: 6 months, 12 months, 18 months ]
  3. Change from baseline MRI assessment [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142842


Locations
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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
Ho Chi Minh, Vietnam
Sponsors and Collaborators
University of Science Ho Chi Minh City
GeneWorld Co., Ltd., Ho Chi Minh
Van Hanh General Hospital
115 People's Hospital, Ho Chi Minh City
Investigators
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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

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Responsible Party: Phuc Van Pham, Laboratory of Stem Cell Research and Apllication, University of Science Ho Chi Minh City
ClinicalTrials.gov Identifier: NCT02142842     History of Changes
Other Study ID Numbers: 1438/QDBYT
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016

Keywords provided by Phuc Van Pham, University of Science Ho Chi Minh City:
Adipose stem cell
Platelet rich plasma
Knee Osteoarthritis
Injured cartilage

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases