Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

NCT03975101 | Withdrawn Phase 1 DMC

• 1 other identifier: VSEL-knee
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stem Cell Transplant Complications; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of knee pain score

  6 months after injection

• Imaging changes in the knee joint

  6 months after injection

• Change of knee pain score

  12 months after injection

• Imaging changes in the knee joint

  12 months after injection

Study Arms (4)

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

Biological: very small embryonic-like stem cell

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

Biological: very small embryonic-like stem cell

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

Biological: very small embryonic-like stem cell

Control

NO INTERVENTION

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

Interventions

very small embryonic-like stem cell 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

Also known as: VSEL

VSEL Max; VSEL Medium; VSEL Mini

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Guangzhou Four-Leaf Clover HealthTech Co., Ltd.: collaborator

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators screen patients with similar knee condition to ensure a small difference, and they randomized different numbers of VSELs to the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 5, 2019
• Study Start: July 5, 2019
• Primary Completion: May 25, 2020
• Study Completion: June 15, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)