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出境医 / 临床实验 / Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
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 : July 5, 2019
Estimated Primary Completion Date : May 25, 2020
Estimated Study Completion Date : June 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 Name: 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 Name: 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 Name: 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 :
  1. Change of knee pain score [ Time Frame: 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 :
  1. Change of knee pain score [ Time Frame: 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

  2. Imaging changes in the knee joint [ Time Frame: 6 months after injection ]
    Magnetic resonance image (MRI) examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage

  3. Change of knee pain score [ Time Frame: 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

  4. Imaging changes in the knee joint [ Time Frame: 12 months after injection ]
    MRI examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Layout table for location information
China, Guangdong
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.
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE July 5, 2019
Estimated Primary Completion Date May 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019) 		Change of knee pain score [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019) 		Reduced knee pain score [ Time Frame: 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Change of knee pain score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months after injection ]
    MRI examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Reduced knee pain score [ Time Frame: 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 [ Time Frame: 6 months after injection ]
    Magnetic resonance image (MRI) examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage
  • Reduced knee pain score [ Time Frame: 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 [ Time Frame: 12 months after injection ]
    MRI examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Very Small Embryonic-like Stem Cells for Knee Osteoarthritis
Official Title  ICMJE Autologous Very Small Embryonic-like Stem Cells(VSELs) for Knee Osteoarthritis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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.
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
Condition  ICMJE
  • Stem Cell Transplant Complications
  • Knee Osteoarthritis
Intervention  ICMJE 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 Name: VSEL
Study Arms  ICMJE
  • 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
    Intervention: Biological: very small embryonic-like stem cell
  • 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
    Intervention: Biological: very small embryonic-like stem cell
  • 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
    Intervention: Biological: very small embryonic-like stem cell
  • No Intervention: Control
    A mean volume of 5.5 mL platelet-rich plasma containing no VSELs injected into the selected knee of the patient
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 13, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2019) 		20
Estimated Study Completion Date  ICMJE June 15, 2020
Estimated Primary Completion Date May 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975101
Other Study ID Numbers  ICMJE VSEL-knee
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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