Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

Fuda Cancer Hospital, Guangzhou

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Stem Cell Transplant Complications; Knee Osteoarthritis

Treatments: Biological: very small embryonic-like stem cell

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03975101

VSEL-knee

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups

VSEL Max

Experimental group

Description:

A mean volume of 5.5 mL platelet-rich plasma containing approximately 120,000 cells were prepared and injected into the selected knee of the patient

Treatment:

Biological: very small embryonic-like stem cell

VSEL Medium

Experimental group

Description:

A mean volume of 5.5 mL platelet-rich plasma containing approximately 90,000 cells were prepared and injected into the selected knee of the patient

Treatment:

Biological: very small embryonic-like stem cell

VSEL Mini

Experimental group

Description:

A mean volume of 5.5 mL platelet-rich plasma containing approximately 60,000 cells were prepared and injected into the selected knee of the patient

Treatment:

Biological: very small embryonic-like stem cell

Control

No Intervention group

Description:

A mean volume of 5.5 mL platelet-rich plasma containing no VSELs injected into the selected knee of the patient