OsteoarthritisPhase 1/2NCT02846675
Safety and Efficacy of Autologous SVF Cells in Treating Patients With Osteoarthritis
A Phase 1/2 study testing autologous SVF in people with Osteoarthritis, run by Shanghai East Hospital at 1 site in China.
Trial summary
it's a self-control, double blind study of autologous adipose-derived stromal vascular fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a feasibility and safety study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- autologous SVF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2014to 31 Jan 2018
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI.
- Study Subjects must have failed a minimum of at least two conservative therapies, spanning a period of at least 3 months.
- Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
- Subjects will be in good health (ASA Class I-II) with a BMI < 35.
- Subjects must have continued pain in the knee despite conservative therapies for at least 3 months.
- Subjects with unilateral disease must present with symptomatic knee pain using the WOMAC subscale for pain.
- Subjects must speak, read and understand English.
- Subjects must be reasonably able to return for multiple follow-up visits.
Who cannot join
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study.
- Life expectancy < 6 months due to concomitant illnesses.
- Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- Patients on chronic immunosuppressive transplant therapy
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- Systolic blood pressure (supine) ≤90 mm Hg or greater than 180mmHg
- Resting heart rate > 100 bpm;
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- Active clinical infection
- Unwilling and/or not able to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Self-control Study: Safety and Efficacy of Autologous Adipose-Derived SVF Cells Delivered Intra-articularly in Patients With Osteoarthritis
it's a self-control, double blind study of autologous adipose-derived stromal vascular fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a feasibility and safety study.
Read the detailed description
The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension of the SVF in 2 ml saline, with at least 50 million nucleated SVF cells and a mean viability of 85%, injected per single knee and the other knee treated with placebo.
Cell suspension and placebo will be injected using ultrasound guidance. Safety and knee function will be evaluated by questionaires monthly and MRI in every three months post-op.
- Conditions
- Osteoarthritis
- Being tested
- autologous SVF, Placebo
- Keywords
- SVF, Stromal Vascular Fraction, osteoarthritis(OA), knee, adipose
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous SVFBiological
Also called Stromal Vascular Fraction
SVF will be obtained from lipoaspirates of subjects which will contain more than 5 millions nucleated cells.
PlaceboBiological
a Placebo treatment without SVF cells
| Study group | Role | What they receive |
|---|---|---|
| SVF treatment (random knee) | Experimental | A random knee (left or right) of subjects will be treated with autologous SVF. Receives: Biological: autologous SVF |
| placebo treatment (the other knee) | Placebo comparator | The other knee of subjects will be treated with placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Subjects will be monitored for adverse events
Measured: 6 months
Secondary outcomes (3)
Change in Pain Scores on the WOMAC Scale at All Follow-up Visits
Patients outcomes for pain will be scored through questionaires
Measured: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Change in Function Scores on the WOMAC Scale at All Follow-up Visits
Patients outcomes for knee function will be scored through questionaires
Measured: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Change from baseline in MRI imaging
Knee function will be assessed by MRI at three time points: pre-op, 3 months and 6 months post-op
Measured: 3 months & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start1 Nov 2014
- Primary completion31 Jul 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yin Feng, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846675
- Sponsor's protocol ID
- DFSC-2014(CR)-03
- Status last verified
- Sep 2018
- First submitted
- 25 Jul 2016
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-control Study: Safety and Efficacy of Autologous Adipose-Derived SVF Cells Delivered Intra-articularly in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT02846675
- Acronym / sponsor ID
- DFSC-2014(CR)-03
- Conditions
- Osteoarthritis
- Keywords
- SVF, Stromal Vascular Fraction, osteoarthritis(OA), knee, adipose
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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.
it's a self-control, double blind study of autologous adipose-derived stromal vascular fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a feasibility and safety study.
Detailed description
The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension of the SVF in 2 ml saline, with at least 50 million nucleated SVF cells and a mean viability of 85%, injected per single knee and the other knee treated with placebo.
Cell suspension and placebo will be injected using ultrasound guidance. Safety and knee function will be evaluated by questionaires monthly and MRI in every three months post-op.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVF treatment (random knee) | Experimental | Biological: autologous SVFA random knee (left or right) of subjects will be treated with autologous SVF. |
| placebo treatment (the other knee) | Placebo comparator | Biological: PlaceboThe other knee of subjects will be treated with placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI.
- Study Subjects must have failed a minimum of at least two conservative therapies, spanning a period of at least 3 months.
- Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
- Subjects will be in good health (ASA Class I-II) with a BMI < 35.
- Subjects must have continued pain in the knee despite conservative therapies for at least 3 months.
Key exclusion criteria (12 listed)
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study.
- Life expectancy < 6 months due to concomitant illnesses.
- Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
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 |
|---|---|---|
| autologous SVFAlso: Stromal Vascular FractionSVF will be obtained from lipoaspirates of subjects which will contain more than 5 millions nucleated cells. | Biological | SVF treatment (random knee) |
| Placeboa Placebo treatment without SVF cells | Biological | placebo treatment (the other knee) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 6 months
Subjects will be monitored for adverse events
3 secondary outcomes
Change in Pain Scores on the WOMAC Scale at All Follow-up Visits
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Change in Function Scores on the WOMAC Scale at All Follow-up Visits
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Change from baseline in MRI imaging
Time frame: 3 months & 6 months
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 11 Sep 2018.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing autologous SVF in people with Osteoarthritis, run by Shanghai East 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 8 inclusion and 12 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 11 Sep 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: 6 months). 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 11 Sep 2018.