Osteoarthritis of the KneePhase 1NCT02357485
ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
A Phase 1 study testing ADSC in people with Osteoarthritis of the Knee, run by Fodor, Peter B, M.D..
Trial summary
This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- ADSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to May 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- voluntarily provided written Informed Consent
- ages 20-70
- male or female
- grades I-III radiologically documented OA of one or both knees
- American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35
- knee pain graded as greater than 3 out of 10 on screening questionnaire
- able to speak, read and understand English -
Who cannot join
- patient parameters falling outside of the inclusion criteria
- current oral or parenteral steroid or blood thinner use
- hyaluronic acid-based injection to the affected knee joint within the previous six months
- corticosteroid injection to the affected knee joint within the previous three months
- end stage (Grade IV) OA
About this study
Official title: Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint
This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.
Read the detailed description
This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- ADSC
- Keywords
- ADSC, osteoarthritis, knee, adipose
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSCBiological
Single injection of ADSC
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Single injection of ADSC Receives: Biological: ADSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as Measured by Adverse Events
Adverse Events were recorded during the entirety of the study.
Measured: Entire Study (1 year)
Secondary outcomes (4)
Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Comparison of WOMAC score (pain, stiffness and functionality measures) measured at baseline (pre-treatment), 3 months and 1 year (post treatment).
WOMAC score: 0 (best) to 100 (worst)
Measured: Baseline to 1 year
Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain
Comparison of VAS pain score as measured before treatment and 3 months and 1 year after treatment. VAS measured on a scale of 0 (no pain) to 10 (worst possible pain).
Measured: Baseline to 1 year
Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion
Comparison of baseline measure of knee flexion to 3 months measurements of knee flexion. An increase in range of motion is positive (improved ability to move) and a decrease in range of motion is negative.
Measured: Baseline to 3 months
Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).
Comparison of baseline time for subjects' ability to rapidly rise from a chair, move rapidly 2 meters from the chair, turn and return and sit in the chair to the same measure at 3 months. Time to complete task is measured in seconds.
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of the KneeStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fodor, Peter B, M.D.
- Collaborators
- Plastic Surgery Education and Research Foundation
- Responsible party
- Principal investigator, Peter B. Fodor MD, Fodor, Peter B, M.D.
- Investigators
- Peter B Fodor, M.D., Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357485
- Sponsor's protocol ID
- OAKnee01
- Status last verified
- Jun 2015
- First submitted
- 31 Jan 2015
- Last updated
- 30 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint
- ClinicalTrials.gov ID
- NCT02357485
- Acronym / sponsor ID
- OAKnee01
- Conditions
- Osteoarthritis of the Knee
- Keywords
- ADSC, osteoarthritis, knee, adipose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fodor, Peter B, M.D.
- Collaborators
- Plastic Surgery Education and Research Foundation
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 27 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.
Detailed description
This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Biological: ADSCSingle injection of ADSC |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- voluntarily provided written Informed Consent
- ages 20-70
- male or female
- grades I-III radiologically documented OA of one or both knees
- American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35
Key exclusion criteria (5 listed)
- patient parameters falling outside of the inclusion criteria
- current oral or parenteral steroid or blood thinner use
- hyaluronic acid-based injection to the affected knee joint within the previous six months
- corticosteroid injection to the affected knee joint within the previous three months
- end stage (Grade IV) OA
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 |
|---|---|---|
| ADSCSingle injection of ADSC | Biological | Treatment arm |
Primary outcome
Safety as Measured by Adverse Events
Time frame: Entire Study (1 year)
Adverse Events were recorded during the entirety of the study.
4 secondary outcomes
Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Baseline to 1 year
Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain
Time frame: Baseline to 1 year
Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion
Time frame: Baseline to 3 months
Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).
Time frame: baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Peter B Fodor, M.D. principal investigator
Private Practice
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADSC in people with Osteoarthritis of the Knee, run by Fodor, Peter B, M.D..
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 7 inclusion and 5 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 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety as Measured by Adverse Events (time frame: Entire Study (1 year)). 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 30 Jun 2015.