OsteoarthritisNCT01739504
Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.
A study testing Liposuction with Local Anesthesia and Intra articular infusion of AD-SVF in people with Osteoarthritis, run by Ageless Regenerative Institute at 1 site in United States.
Trial summary
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly to affected joints. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Liposuction with Local Anesthesia and Intra articular infusion of AD-SVF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 1 Apr 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females between Age 18 and 80 years.
- Patient with current proven diagnosis of Osteoarthritis, with consistent symptomatology
- Up to date on all age and gender appropriate cancer screening per American Cancer Society.
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: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra- Articularly in Patients With Osteoarthritis
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly to affected joints.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Osteoarthritis.
Read the detailed description
AD-SVF will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of AD-SVF. In addition, patient's peripheral blood will be collected for isolation of platelet rich plasma (PRP), which are then combined with the AD-SVF for intra-articular administration of affected joint.
- Conditions
- Osteoarthritis
- Being tested
- Liposuction with Local Anesthesia, Intra articular infusion of AD-SVF
- Keywords
- Arthritis, Joint pain, Articular cartilage, Mesenchymal stem cells, Autologous, Adipose tissue
- Medical subject headings
- Osteoarthritis, Arthritis, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposuction with Local AnesthesiaProcedure or surgery
Also called Lipoplasty, Liposculpture, Suction-assisted fat removal
Liposuction under tumescent anesthesia for adipose tissue harvesting.
Intra articular infusion of AD-SVFBiological
Adipose tissue is available in most patients for harvest through minimally invasive procedures such as liposuction. AD-SVF can be obtained in large quantities after processing of adipose tissue in the laboratory.
- AD-SVF to promote tissue regeneration and repair with their ability to secrete various growth factors that can modulate host tissue environment.
- Patient's AD-SVF combined with PRP are used for direct intra-articular injection after processing.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Adipose-derived Stromal Vascular Fraction infusion | Experimental | Intervention: AD-SVF infusion directly into affected joints. Receives: Procedure: Liposuction with Local Anesthesia; Biological: Intra articular infusion of AD-SVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Visual Analogue Scale (VAS)
For pain score, functional rating index, visual analog scale (VAS), physical therapy (PT), and range of motion (ROM) were determined as previously described. The patient was restricted from taking steroids, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) for one week prior to the procedure.
Measured: 3 months, 6 months
Change from Baseline of Quality of life scores
Measured: 3 months, and 6 months
Change from Baseline of Reduction in analgesics
Measured: Baseline, 3 months, 6 months
Number of adverse events reported
Measured: 6 months
Secondary outcomes (1)
Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study start1 Mar 2014
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Why it stopped: company dissolved
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ageless Regenerative Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon McQuillan, MD, Principal investigator, Ageless Regenerative Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739504
- Sponsor's protocol ID
- AD-US-OR-001
- Status last verified
- Sep 2016
- First submitted
- 28 Sep 2012
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra- Articularly in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT01739504
- Acronym / sponsor ID
- AD-US-OR-001
- Conditions
- Osteoarthritis
- Keywords
- Arthritis, Joint pain, Articular cartilage, Mesenchymal stem cells, Autologous, Adipose tissue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: company dissolved
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 3 Dec 2012 (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.
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly to affected joints.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Osteoarthritis.
Detailed description
AD-SVF will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of AD-SVF. In addition, patient's peripheral blood will be collected for isolation of platelet rich plasma (PRP), which are then combined with the AD-SVF for intra-articular administration of affected joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Adipose-derived Stromal Vascular Fraction infusion | Experimental | Procedure: Liposuction with Local Anesthesia, Biological: Intra articular infusion of AD-SVFIntervention: AD-SVF infusion directly into affected joints. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females between Age 18 and 80 years.
- Patient with current proven diagnosis of Osteoarthritis, with consistent symptomatology
- Up to date on all age and gender appropriate cancer screening per American Cancer Society.
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 |
|---|---|---|
| Liposuction with Local AnesthesiaAlso: Lipoplasty, Liposculpture, Suction-assisted fat removalLiposuction under tumescent anesthesia for adipose tissue harvesting. | Procedure or surgery | Autologous Adipose-derived Stromal Vascular Fraction infusion |
| Intra articular infusion of AD-SVFAdipose tissue is available in most patients for harvest through minimally invasive procedures such as liposuction. AD-SVF can be obtained in large quantities after processing of adipose tissue in the laboratory. * AD-SVF to promote tissue regeneration and repair with their ability to secrete various growth factors that can modulate host tissue environment. * Patient's AD-SVF combined with PRP are used for direct intra-articular injection after processing. | Biological | Autologous Adipose-derived Stromal Vascular Fraction infusion |
Primary outcome
Change from Baseline in Visual Analogue Scale (VAS)
Time frame: 3 months, 6 months
For pain score, functional rating index, visual analog scale (VAS), physical therapy (PT), and range of motion (ROM) were determined as previously described. The patient was restricted from taking steroids, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) for one week prior to the procedure.
Change from Baseline of Quality of life scores
Time frame: 3 months, and 6 months
Change from Baseline of Reduction in analgesics
Time frame: Baseline, 3 months, 6 months
Number of adverse events reported
Time frame: 6 months
1 secondary outcome
Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: company dissolved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Sharon McQuillan, MD principal investigator
Ageless Regenerative Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposuction with Local Anesthesia and Intra articular infusion of AD-SVF in people with Osteoarthritis, run by Ageless Regenerative Institute at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 24 Nov 2017. 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 United States. 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 was stopped early (reason given: company dissolved). Results are not available in the source record.
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?
Change from Baseline in Visual Analogue Scale (VAS) (time frame: 3 months, 6 months). The study lists 4 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 24 Nov 2017.