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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142842
• Other study ID #: 1438/QDBYT
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 16, 2014
• Last updated: January 20, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of Science Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Scientific and Ethic Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Autologous adipose tissue stromal vascular fraction and platelet rich plasma

Locations

Country	Name	City	State
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

Sponsors (4)

Lead Sponsor	Collaborator
University of Science Ho Chi Minh City	115 People's Hospital, Ho Chi Minh City, GeneWorld Co., Ltd., Ho Chi Minh, Van Hanh General Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		6 months	Yes
Secondary	Change from the baseline pain score (VAS) at 6 months		6 months, 12 months, 18 months	No
Secondary	Change from baseline Lysholm score at 6 months		6 months, 12 months, 18 months	No
Secondary	Change from baseline MRI assessment		12 months	No