Knee OsteoarthritisNCT05019378
SVF Therapy for Human Knee Osteoarthritis
A study testing SVF treatment in people with Knee Osteoarthritis, run by Zhongnan Hospital at 1 site in China.
Trial summary
The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- SVF treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2016to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Knee Osteoarthritis
- Articular cartilage defect grades I/II of both knee
Who cannot join
- autoimmune or inflammatory arthritis
- serious medical disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Autologous Stromal Vascular Fraction Therapy for Knee Osteoarthritis
The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.
Read the detailed description
Study participants voluntarily provided written informed consent to participate in the study. The two knees of each patient were randomly assigned to autologous SVF treatment group or non-treatment control group. The patients were evaluated every 4 weeks for safety and efficacy of autologous SVF therapy for 24 weeks.
- Conditions
- Knee Osteoarthritis
- Being tested
- SVF treatment
- Keywords
- Cartilage Defect, Cartilage Regeneration
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVF treatmentProcedure or surgery
autologous SVF (10E8 cells)
| Study group | Role | What they receive |
|---|---|---|
| autologous SVF treatment | Experimental | Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint Receives: Procedure: SVF treatment |
| Placebo group | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic evaluation of knee articular cartilage Volume
The Volume (cubic millimeter) of knee articular cartilage are measured.
Measured: Change from Baseline articular cartilage Volume at 12 weeks
Radiologic evaluation of knee articular cartilage Volume
The Volume (cubic millimeter) of knee articular cartilage are measured.
Measured: Change from Baseline articular cartilage Volume at 24 weeks
Radiologic evaluation of knee articular cartilage Area
The Area (square millimeter) of knee articular cartilage are measured.
Measured: Change from Baseline articular cartilage Area at 12 weeks
Radiologic evaluation of knee articular cartilage Area
The Area (square millimeter) of knee articular cartilage are measured.
Measured: Change from Baseline articular cartilage Area at 24 weeks
Radiologic evaluation of knee articular cartilage Thickness
The Thickness (millimeter) of knee articular cartilage are measured.
Measured: Change from Baseline articular cartilage Thickness at 12 weeks
Radiologic evaluation of knee articular cartilage Thickness
The Thickness (millimeter) of knee articular cartilage are measured.
Measured: Change from Baseline articular cartilage Thickness at 24 weeks
Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome.
Measured: Change from Baseline WOMAC arthritis index score at 12 weeks.
Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome.
Measured: Change from Baseline WOMAC arthritis index score at 24 weeks.
Knee pain evaluation and functional evaluation (The Lysholm Knee Scoring Scale)
The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome.
Measured: Change from Baseline Lysholm Knee Scale score at 12 weeks.
Knee pain evaluation and functional evaluation (The Lysholm Knee Scale)
The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome.
Measured: Change from Baseline Lysholm Knee Scale score at 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start19 Dec 2016
- Primary completion23 Aug 2018
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Xiao Zheng, MD, Principal investigator, Wuhan UniversityLin Cai, MD, Study director, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019378
- Sponsor's protocol ID
- Zhongnanzxx
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Autologous Stromal Vascular Fraction Therapy for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05019378
- Acronym / sponsor ID
- Zhongnanzxx
- Conditions
- Knee Osteoarthritis
- Keywords
- Cartilage Defect, Cartilage Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.
Detailed description
Study participants voluntarily provided written informed consent to participate in the study. The two knees of each patient were randomly assigned to autologous SVF treatment group or non-treatment control group. The patients were evaluated every 4 weeks for safety and efficacy of autologous SVF therapy for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autologous SVF treatment | Experimental | Procedure: SVF treatmentThree milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint |
| Placebo group | No intervention | –No treatment |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Knee Osteoarthritis
- Articular cartilage defect grades I/II of both knee
Key exclusion criteria (2 listed)
- autoimmune or inflammatory arthritis
- serious medical disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SVF treatmentautologous SVF (10E8 cells) | Procedure or surgery | autologous SVF treatment |
Primary outcome
Radiologic evaluation of knee articular cartilage Volume
Time frame: Change from Baseline articular cartilage Volume at 12 weeks
The Volume (cubic millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Volume
Time frame: Change from Baseline articular cartilage Volume at 24 weeks
The Volume (cubic millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Area
Time frame: Change from Baseline articular cartilage Area at 12 weeks
The Area (square millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Area
Time frame: Change from Baseline articular cartilage Area at 24 weeks
The Area (square millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Thickness
Time frame: Change from Baseline articular cartilage Thickness at 12 weeks
The Thickness (millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Thickness
Time frame: Change from Baseline articular cartilage Thickness at 24 weeks
The Thickness (millimeter) of knee articular cartilage are measured.
Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
Time frame: Change from Baseline WOMAC arthritis index score at 12 weeks.
Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome.
Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
Time frame: Change from Baseline WOMAC arthritis index score at 24 weeks.
Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome.
Knee pain evaluation and functional evaluation (The Lysholm Knee Scoring Scale)
Time frame: Change from Baseline Lysholm Knee Scale score at 12 weeks.
The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome.
Knee pain evaluation and functional evaluation (The Lysholm Knee Scale)
Time frame: Change from Baseline Lysholm Knee Scale score at 24 weeks.
The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
Related trials for Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Xiao Zheng, MD principal investigator
Wuhan University
Lin Cai, MD study director
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SVF treatment in people with Knee Osteoarthritis, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiologic evaluation of knee articular cartilage Volume (time frame: Change from Baseline articular cartilage Volume at 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.