Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

Sponsor

Fuda Cancer Hospital, Guangzhou (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03975101

Collaborator

Guangzhou Four-Leaf Clover HealthTech Co., Ltd. (Industry)

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplant Complications Knee Osteoarthritis	Biological: very small embryonic-like stem cell	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Investigator)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 5, 2019

Anticipated Primary Completion Date :

May 25, 2020

Anticipated Study Completion Date :

Jun 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Change of knee pain score [6 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
Imaging changes in the knee joint [6 months after injection]
Magnetic resonance image (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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biological treatment center in Fuda cancer hospital	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fuda Cancer Hospital, Guangzhou

ClinicalTrials.gov Identifier:

NCT03975101

Other Study ID Numbers:

VSEL-knee

First Posted:

Jun 5, 2019

Last Update Posted:

Oct 19, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Oct 19, 2020