Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-05

Study Completion Date

2020-06-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stem Cell Transplant Complications Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three experimental groups were injected with different doses of VSEL, and the control group was injected with platelet-containing serum that dissolved VSEL.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The investigators screen patients with similar knee condition to ensure a small difference, and they randomized different numbers of VSELs to the patients.

Study Groups

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VSEL Max

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

Group Type EXPERIMENTAL

very small embryonic-like stem cell

Intervention Type BIOLOGICAL

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

VSEL Medium

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

Group Type EXPERIMENTAL

very small embryonic-like stem cell

Intervention Type BIOLOGICAL

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

VSEL Mini

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

Group Type EXPERIMENTAL

very small embryonic-like stem cell

Intervention Type BIOLOGICAL

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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VSEL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No