Clinical trial NCT02142842: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Knee Osteoarthritis
Keywords: Adipose stem cell
Platelet rich plasma
Knee Osteoarthritis
Injured cartilage
Lead sponsor: University of Science Ho Chi Minh City
Sponsor class: OTHER
Collaborators: name: GeneWorld Co., Ltd., Ho Chi Minh
name: Van Hanh General Hospital
name: 115 People's Hospital
First posted: 2014-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: 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).

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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Change from the baseline pain score (VAS) at 6 months
timeFrame: 6 months, 12 months, 18 months
measure: Change from baseline Lysholm score at 6 months
timeFrame: 6 months, 12 months, 18 months
measure: Change from baseline MRI assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: 115 Hospital, Ho Chi Minh city
city: Ho Chi Minh
country: Vietnam
facility: Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
city: Ho Chi Minh
country: Vietnam
facility: Van Hanh Hospital, Ho Chi Minh city, VN
Study officials:
affiliation: Laboratory of Stem Cell Research and Application, University of Science, VNU-HCM, VN
name: Phuc V Pham, PhD
role: STUDY_DIRECTOR
affiliation: Van Hanh Hospital, Ho Chi Minh city, VN
name: Phuong TB Le, MSc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 115 Hospital, HCM
name: Phu D Nguyen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Van Hanh Hospital, Ho Chi Minh city, VN
name: Ho H La, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Van Hanh Hospital, Ho Chi Minh city, VN
name: Tung DX Tran, MSc, MD
role: PRINCIPAL_INVESTIGATOR
References: