NCT03975101 - Very Small Embryonic-like Stem Cells for Knee Osteoarthritis | Crick

Overview

The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to knee osteoarthritis.

VSELs come from the patient's peripheral blood, and will be injected in the most painful knee, or the worse knee on physical examination. Then follow-up the knee pain and imaging changes at 6 months and 1 year after treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Stem Cell Transplant Complications Knee Osteoarthritis

Interventions

very small embryonic-like stem cellBIOLOGICAL

Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation

Eligibility

Sex: ALLMin age: 50 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients had moderate to severe osteoarthritis of both knees. * Those had mechanical pain of knee joints, which was aggravated by walking or stair climbing. * Those complained of gelling pain of knee joint. * Those have crepitus and limitation of the joint range of motion with joint bony hypertrophy on physical examination, X-rays showed narrowing of joint space and osteophyte formation Exclusion Criteria: * Diabetic foot and patients with obvious edema in the legs caused by various causes * Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin

Locations (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Change of knee pain score

Pain assessment by visual analogue score (VAS). 0 point: no pain; 1-3 points: there is a slight pain that can be tolerated; 4-6 points: the patient has pain and affects sleep, and can still bear it; 7-10 points: the patient has progressively strong pain, pain is unbearable, affecting appetite and sleep

Time frame: 2-4 weeks after injection

Secondary Outcomes

Change of knee pain score

Pain assessment by visual analogue score (VAS). 0 point: no pain; 1-3 points: there is a slight pain that can be tolerated; 4-6 points: the patient has pain and affects sleep, and can still bear it; 7-10 points: the patient has progressively strong pain, pain is unbearable, affecting appetite and sleep

Time frame: 6 months after injection

Imaging changes in the knee joint

Magnetic resonance image (MRI) examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage

Time frame: 6 months after injection

Change of knee pain score

Pain assessment by visual analogue score (VAS). 0 point: no pain; 1-3 points: there is a slight pain that can be tolerated; 4-6 points: the patient has pain and affects sleep, and can still bear it; 7-10 points: the patient has progressively strong pain, pain is unbearable, affecting appetite and sleep

Time frame: 12 months after injection

Imaging changes in the knee joint

MRI examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage

Time frame: 12 months after injection