Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01947348|
Recruitment Status : Unknown
Verified September 2014 by barbara krutchkoff, Institute of Regenerative and Cellular Medicine.
Recruitment status was: Recruiting
First Posted : September 20, 2013
Last Update Posted : September 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: treatment with A3 SVF||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2015|
Experimental: treatment with A3 SVF
These patients that have been treated. The control patients that have not been treated.
Procedure: treatment with A3 SVF
Treatment interarticular and IV with A3 SVF
Other Name: A3 SVF, Cell Extracts, Adipose Derived Stem Cells
- Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel [ Time Frame: one year ]
- Pain and Mobility Assessment [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947348
|Contact: John Huh, MD||213 384 1717|
|United States, California|
|Dr John Huh||Recruiting|
|Los Angeles, California, United States, 90020|
|Contact: John Huh, MD 213-384-1717 email@example.com|
|Principal Investigator: John Huh, MD|
|Study Chair:||Barbara Krutchkoff||Institute of Regenerative and Cellular Medicine|
|Principal Investigator:||John Huh, MD||ICMS|