Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03975101
• Other study ID #: VSEL-knee
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 5, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: May 2020
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 15, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Stem Cell Transplant Complications

Intervention

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

Locations

Country	Name	City	State
China	Biological treatment center in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2-4 weeks after injection
Secondary	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	6 months after injection
Secondary	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	6 months after injection
Secondary	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	12 months after injection
Secondary	Imaging changes in the knee joint	MRI examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage	12 months after injection