Trial | NCT03975101  Report issue

Title

Very Small Embryonic-like Stem Cells for Knee Osteoarthritis
Autologous Very Small Embryonic-like Stem Cells(VSELs) for Knee Osteoarthritis

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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 Started
Jul 05
2019
Primary Completion
May 25
2020
Anticipated
Study Completion
Jun 15
2020
Anticipated
Last Update
Oct 19
2020

Biological very small embryonic-like stem cell

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

  • Other names: VSEL

VSEL Max Experimental

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

VSEL Medium Experimental

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

VSEL Mini Experimental

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

Control No Intervention

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

Criteria 

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
No Results Posted