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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deployment of stromal vascular fraction | Experimental | Administration of autologous adipose derived SVF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of autologous adipose derived SVF | Procedure | Intra-venous, intra-articular, and soft tissue injection delivery of SVF |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark H Berman, MD | Cell surgical network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Stem Cell Treatment Center | Rancho Mirage | California | 92270 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25974235 | Derived | Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871. No abstract available. |
| Label | URL |
|---|---|
| cell surgical network | View source |
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Finishing 1000 patient safety paper for peer review and publication.
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| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. |
| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D010003 | Osteoarthritis |
| D007172 | Erectile Dysfunction |
| D001327 | Autoimmune Diseases |
| D009202 | Cardiomyopathies |
| D004646 | Emphysema |
| D018856 | Cystitis, Interstitial |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001168 | Arthritis |
| D009103 | Multiple Sclerosis |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D007154 | Immune System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
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