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Trial record 29 of 55 for:    stem cell arthritis AND stem cell transplantation

Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03975101
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 : December 15, 2019
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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



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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975101


Contacts
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Contact: Jibing Chen, PhD +86-18903068207 jibingchen398@163.com

Locations
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China, Guangdong
Biological treatment center in Fuda cancer hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Chen Jibing, PhD    +86-18903068207    jibingchen398@163.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03975101     History of Changes
Other Study ID Numbers: VSEL-knee
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases