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Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis

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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
Sponsor:
Information provided by (Responsible Party):
barbara krutchkoff, Institute of Regenerative and Cellular Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: treatment with A3 SVF Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Pain and Mobility Assessment [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: John Huh, MD 213 384 1717

Locations
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United States, California
Dr John Huh Recruiting
Los Angeles, California, United States, 90020
Contact: John Huh, MD    213-384-1717    drjhuh@gmail.com   
Principal Investigator: John Huh, MD         
Sponsors and Collaborators
Institute of Regenerative and Cellular Medicine
Investigators
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Study Chair: Barbara Krutchkoff Institute of Regenerative and Cellular Medicine
Principal Investigator: John Huh, MD ICMS
More Information
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Additional Information:
IRB  This link exits the ClinicalTrials.gov site

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Responsible Party: barbara krutchkoff, Dr John Huh, Los Angeles, Institute of Regenerative and Cellular Medicine
ClinicalTrials.gov Identifier: NCT01947348    
Other Study ID Numbers: A3-912-OA-801
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases