Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

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

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

Study Overview

• Status: Withdrawn
• Conditions: Knee Osteoarthritis; Stem Cell Transplant Complications
• Intervention / Treatment: Biological: very small embryonic-like stem cell

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Biological treatment center in Fuda cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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
EXPERIMENTAL: 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	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
EXPERIMENTAL: 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	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
NO_INTERVENTION: Control; A mean volume of 5.5 mL platelet-rich plasma containing no VSELs injected into the selected knee of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Fuda Cancer Hospital, Guangzhou
• Collaborators: Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 5, 2019
• Primary Completion (ANTICIPATED): May 25, 2020
• Study Completion (ANTICIPATED): June 15, 2020

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (ACTUAL): June 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: VSEL-knee

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No