To evaluate for any adverse effects that may be related to the administration and reception of autologous adipose derived stromal vascular fraction (SVF). Secondarily, the study monitors the results of subjective and objective findings as it applies to the non-blinded deployment of autologous SVF for various inflammatory and/or degenerative conditions including select orthopedic, neurologic, urologic and cardio-pulmonary conditions. SVF deployments include intra-venous, intra-articular, and soft tissue injections.
SVF Stromal Vascular Fraction is obtained by lipoharvesting, procurement, and lipo-transfer as a same day operative procedure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3,000
Intra-venous, intra-articular, and soft tissue injection delivery of SVF
California Stem Cell Treatment Center
Rancho Mirage, California, United States
Number of participants with adverse events
Outcome measures will include the number of participants with adverse events related to either SVF deployment or the lipo-harvesting procedure.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
Changes in the Oswestry Disability Index
Changes in the Oswestry Disability Index Score will be measured. Outcomes represent changes from baseline in symptom and abilities scores on 11 questions.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
Changes in the Neck Disability Index
Changes in the Neck Disability Index Score will be measured. Outcomes represent changes from baseline in symptom and abilities scores on 10 questions.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
Changes in Koos Physical Function Shortform
Changes in Koos Physical Function Shortform will be measured. Outcomes represent changes in level of function score from none to extreme.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
Changes in Hoos Physical Function Shortform
Changes in Hoos Physical Function Shortform will be measured. Outcomes represent changes in level of function score from none to extreme.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
Changes in the DASH questionnaire
Changes in the DASH Questionnaire Score will be measured. Outcomes represent changes from baseline in symptoms and abilities scores on 11 questions.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
Changes in the Visual Analog Pain Score
Changes in the Visual Analog Pain Score will be measured. Outcomes represent changes from baseline from none to severe.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
Changes in the Aqol-4
Changes in the Aqol-4 Assessment of Quality of Life Instrument will be measured. Outcomes represent changes from baseline in 12 subjective scores.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
Changes in the O'leary-Sant IC Questionnaire
Changes in the O'leary-Sant IC Questionnaire will be measured. Outcomes represent changes from baseline in 8 symptom and problem scores
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
Changes in PUF Symptom Scale
Changes in the PUF Symptom Scale will be measured. Outcomes represent changes from baseline in in 8 symptom and bother scores.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
Changes in the IIEF Questionnaire
Changes in the IIEF Questionnaire Score will be measured. Outcomes represent changes in erectile function from baseline in 5 sexual function scores.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
EHGS Grading Score measuring change in hardness score
Changes in the EHGS Grading Score will be measured. Outcomes represent changes from baseline in erection hardness on a scale of 1 to 4.
Time frame: Outcome measures will be evaluated at baseline, 3,6,9,12,15,18,21,24,27,30,33,36 months. Outcomes tests will be given yearly after 36 months for an average time frame of 5 years and estimated time frame maximum of 10 years.
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