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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

Tracking Information
First Submitted Date  ICMJE May 16, 2014
First Posted Date  ICMJE May 20, 2014
Last Update Posted Date January 22, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
Number of participants with adverse events [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02142842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
  • Change from the baseline pain score (VAS) at 6 months [ Time Frame: 6 months, 12 months, 18 months ]
  • Change from baseline Lysholm score at 6 months [ Time Frame: 6 months, 12 months, 18 months ]
  • Change from baseline MRI assessment [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Adipose Stem Cells and Platelet Rich Plasma Therapy for Patients With Knee Osteoarthritis
Official Title  ICMJE Phase I/II Study of Transplantation of Autologous Adipose Stem Cells and Activated Platelet Rich Plasma in Knee Osteoarthritis Treatment
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Biological: Autologous adipose tissue stromal vascular fraction and platelet rich plasma
Study Arms  ICMJE 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.
Intervention: Biological: Autologous adipose tissue stromal vascular fraction and platelet rich plasma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2015)
30
Original Actual Enrollment  ICMJE
 (submitted: May 16, 2014)
32
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02142842
Other Study ID Numbers  ICMJE 1438/QDBYT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phuc Van Pham, University of Science Ho Chi Minh City
Study Sponsor  ICMJE University of Science Ho Chi Minh City
Collaborators  ICMJE
  • GeneWorld Co., Ltd., Ho Chi Minh
  • Van Hanh General Hospital
  • 115 People's Hospital, Ho Chi Minh City
Investigators  ICMJE
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
PRS Account University of Science Ho Chi Minh City
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP