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Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

Primary Purpose

Stem Cell Transplant Complications, Knee Osteoarthritis

Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
very small embryonic-like stem cell
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stem Cell Transplant Complications

Eligibility Criteria

50 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Biological treatment center in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

VSEL Max

VSEL Medium

VSEL Mini

Control

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Imaging changes in the knee joint
MRI examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage

Full Information

First Posted
May 31, 2019
Last Updated
October 13, 2020
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03975101
Brief Title
Very Small Embryonic-like Stem Cells for Knee Osteoarthritis
Official Title
Autologous Very Small Embryonic-like Stem Cells(VSELs) for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Policy changes have contributed to the failure to carry out smoothly
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
May 25, 2020 (Anticipated)
Study Completion Date
June 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Transplant Complications, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VSEL Max
Arm Type
Experimental
Arm Description
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
Arm Title
VSEL Medium
Arm Type
Experimental
Arm Description
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
Arm Title
VSEL Mini
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
A mean volume of 5.5 mL platelet-rich plasma containing no VSELs injected into the selected knee of the patient
Intervention Type
Biological
Intervention Name(s)
very small embryonic-like stem cell
Other Intervention Name(s)
VSEL
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of knee pain score
Description
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
Time Frame
2-4 weeks after injection
Secondary Outcome Measure Information:
Title
Change of knee pain score
Description
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
Time Frame
6 months after injection
Title
Imaging changes in the knee joint
Description
Magnetic resonance image (MRI) examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage
Time Frame
6 months after injection
Title
Change of knee pain score
Description
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
Time Frame
12 months after injection
Title
Imaging changes in the knee joint
Description
MRI examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage
Time Frame
12 months after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Biological treatment center in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

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