OsteoarthritisNCT01947348
Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
A study testing treatment with A3 SVF in people with Osteoarthritis, run by Institute of Regenerative and Cellular Medicine at 1 site in United States.
Trial summary
To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction) has an effect on pain and inflammation associated with Osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- treatment with A3 SVF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2015
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
- Patients range from 15-90 years of age.
- Female patients not pregnant or lactating.
- Patients with a history of or current corticosteroid therapy will only be eligible if use is suspended from 1 month prior to cell therapy.
- Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
- Patients with adequate renal function, creatinine ≤ 1.5 mg/dl.
- Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT <1.5×control.
Who cannot join
- Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
- Signs and symptoms of clinically significant cardiac disease.
- Diagnosis of a transient ischemic attack in the 6 months prior to screening,
- Known allergy to anesthetic or any other components of study.
- Patients infected with hepatitis B, C or HIV.
- Patients with Body Mass Index (BMI) > 39kg/m2 .
- Any other cardiovascular illness that in the opinion of the investigator would render a patient unsuitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
John Huh, MD contact
United States1 site, 1 recruiting
- Recruiting
Dr John Huh
Los Angeles, California, 90020
John Huh, MD, 213-384-1717, drjhuh@gmail.com
John Huh, MD
About this study
To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction) has an effect on pain and inflammation associated with Osteoarthritis.
Read the detailed description
This is a prospective non-randomized, clinical study of 30 patients to determine safety and treatment potential of A3(Adult Autologous Adipose) SVF for the pain and inflammation associated with Osteoarthritis.
Patients will be treated for Osteoarthritis due to degeneration or chronic injury. They will be given autologous SVF extract derived by the A3 method mixed with activated platelets from a PRP(platelet rich plasma) preparation as direct injections to the effected joints. Outcomes will be tracked with WOMAC (Western Ontario and McMaster Universities Arthritis Index), AUSCAN(Australian Hand Osteoarthritis Index) scores, and a general blood panel in order to evaluate systemic effects.
- Conditions
- Osteoarthritis
- Being tested
- treatment with A3 SVF
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with A3 SVFProcedure or surgery
Also called A3 SVF, Cell Extracts, Adipose Derived Stem Cells
Treatment interarticular and IV with A3 SVF
| Study group | Role | What they receive |
|---|---|---|
| treatment with A3 SVF | Experimental | These patients that have been treated. The control patients that have not been treated. Receives: Procedure: treatment with A3 SVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel
Measured: one year
Secondary outcomes (1)
Pain and Mobility Assessment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Regenerative and Cellular Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, barbara krutchkoff, Institute of Regenerative and Cellular Medicine
- Investigators
- Barbara Krutchkoff, Study chair, Institute of Regenerative and Cellular MedicineJohn Huh, MD, Principal investigator, ICMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947348
- Sponsor's protocol ID
- A3-912-OA-801
- Status last verified
- Sep 2014
- First submitted
- 15 Mar 2013
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
- ClinicalTrials.gov ID
- NCT01947348
- Acronym / sponsor ID
- A3-912-OA-801
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Regenerative and Cellular MedicineIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 20 Sep 2013 (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.
To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction) has an effect on pain and inflammation associated with Osteoarthritis.
Detailed description
This is a prospective non-randomized, clinical study of 30 patients to determine safety and treatment potential of A3(Adult Autologous Adipose) SVF for the pain and inflammation associated with Osteoarthritis.
Patients will be treated for Osteoarthritis due to degeneration or chronic injury. They will be given autologous SVF extract derived by the A3 method mixed with activated platelets from a PRP(platelet rich plasma) preparation as direct injections to the effected joints. Outcomes will be tracked with WOMAC (Western Ontario and McMaster Universities Arthritis Index), AUSCAN(Australian Hand Osteoarthritis Index) scores, and a general blood panel in order to evaluate systemic effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment with A3 SVF | Experimental | Procedure: treatment with A3 SVFThese patients that have been treated. The control patients that have not been treated. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
- Patients range from 15-90 years of age.
- Female patients not pregnant or lactating.
- Patients with a history of or current corticosteroid therapy will only be eligible if use is suspended from 1 month prior to cell therapy.
- Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
Key exclusion criteria (7 listed)
- Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
- Signs and symptoms of clinically significant cardiac disease.
- Diagnosis of a transient ischemic attack in the 6 months prior to screening,
- Known allergy to anesthetic or any other components of study.
- Patients infected with hepatitis B, C or HIV.
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 |
|---|---|---|
| treatment with A3 SVFAlso: A3 SVF, Cell Extracts, Adipose Derived Stem CellsTreatment interarticular and IV with A3 SVF | Procedure or surgery | treatment with A3 SVF |
Primary outcome
Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel
Time frame: one year
1 secondary outcome
Pain and Mobility Assessment
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
- IRBLink provided by the sponsor.
- Info regarding outcome measuresLink provided by the sponsor.
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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.
John Huh, MD contact
Barbara Krutchkoff study chair
Institute of Regenerative and Cellular Medicine
John Huh, MD principal investigator
ICMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment with A3 SVF in people with Osteoarthritis, run by Institute of Regenerative and Cellular Medicine 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Sep 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Huh, MD (213 384 1717), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel (time frame: one 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 4 Sep 2014.