Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

Phase 1

Withdrawn

• Conditions: Stem Cell Transplant Complications; Knee Osteoarthritis
• Interventions: Biological: very small embryonic-like stem cell

• Registration Number: NCT03975101
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-05
• Study Start: 2019-07-05
• Status Verified: 2020-05
• Primary Completion: 2020-05-25
• Study Completion: 2020-06-15
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSEL Max	very small embryonic-like stem cell	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 Mini	very small embryonic-like stem cell	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
VSEL Medium	very small embryonic-like stem cell	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

Primary Outcome Measures

Name	Time	Method
Change of knee pain score	2-4 weeks after injection	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

Secondary Outcome Measures

Name	Time	Method
Imaging changes in the knee joint	12 months after injection	MRI examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage
Change of knee pain score	12 months after injection	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

Trial Locations

Locations (1)

Biological treatment center in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China