Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
NCT ID: NCT01947348
Last Updated: 2014-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2012-09-30
2015-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment with A3 SVF
These patients that have been treated. The control patients that have not been treated.
treatment with A3 SVF
Treatment interarticular and IV with A3 SVF
Interventions
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treatment with A3 SVF
Treatment interarticular and IV with A3 SVF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Institute of Regenerative and Cellular Medicine
INDUSTRY
Responsible Party
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barbara krutchkoff
Dr John Huh, Los Angeles
Principal Investigators
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Barbara Krutchkoff
Role: STUDY_CHAIR
Institute of Regenerative and Cellular Medicine
John Huh, MD
Role: PRINCIPAL_INVESTIGATOR
ICMS
Locations
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Dr John Huh
Los Angeles, California, United States
Countries
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Central Contacts
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John Huh, MD
Role: CONTACT
Facility Contacts
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Related Links
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Info regarding outcome measures
Other Identifiers
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A3-912-OA-801
Identifier Type: -
Identifier Source: org_study_id
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