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Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions

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ClinicalTrials.gov Identifier: NCT01953523
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Elliot Lander, Cell Surgical Network Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neurodegenerative Diseases Osteoarthritis Erectile Dysfunction Autoimmune Diseases Cardiomyopathies Emphysema Procedure: Administration of autologous adipose derived SVF Not Applicable

Detailed Description:
SVF Stromal Vascular Fraction is obtained by lipoharvesting, procurement, and lipo-transfer as a same day operative procedure

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Intervention Study: Adverse Events and Clinical Outcomes for the Deployment of Adipose Derived SVF (Rich in Adult Stem Cells and Growth Factors)for Select Orthopedic, Neurologic, Urologic, and Cardio-Pulmonary Conditions.
Actual Study Start Date : September 2, 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : January 1, 2017

Arm Intervention/treatment
Experimental: Deployment of stromal vascular fraction
Administration of autologous adipose derived SVF
Procedure: Administration of autologous adipose derived SVF
Intra-venous, intra-articular, and soft tissue injection delivery of SVF




Primary Outcome Measures :
  1. Number of participants with adverse events [ 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. ]
    Outcome measures will include the number of participants with adverse events related to either SVF deployment or the lipo-harvesting procedure.


Secondary Outcome Measures :
  1. Changes in the Oswestry Disability Index [ 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 Score will be measured. Outcomes represent changes from baseline in symptom and abilities scores on 11 questions.

  2. Changes in the Neck Disability Index [ 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 Score will be measured. Outcomes represent changes from baseline in symptom and abilities scores on 10 questions.

  3. Changes in Koos Physical Function Shortform [ 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 will be measured. Outcomes represent changes in level of function score from none to extreme.

  4. Changes in Hoos Physical Function Shortform [ 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 will be measured. Outcomes represent changes in level of function score from none to extreme.

  5. Changes in the DASH questionnaire [ 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 Score will be measured. Outcomes represent changes from baseline in symptoms and abilities scores on 11 questions.

  6. Changes in the Visual Analog Pain Score [ 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 will be measured. Outcomes represent changes from baseline from none to severe.

  7. Changes in the Aqol-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. ]
    Changes in the Aqol-4 Assessment of Quality of Life Instrument will be measured. Outcomes represent changes from baseline in 12 subjective scores.

  8. Changes in the O'leary-Sant IC Questionnaire [ 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 will be measured. Outcomes represent changes from baseline in 8 symptom and problem scores

  9. Changes in PUF Symptom Scale [ 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 PUF Symptom Scale will be measured. Outcomes represent changes from baseline in in 8 symptom and bother scores.

  10. Changes in the IIEF Questionnaire [ 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 Score will be measured. Outcomes represent changes in erectile function from baseline in 5 sexual function scores.

  11. EHGS Grading Score measuring change in hardness score [ 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 EHGS Grading Score will be measured. Outcomes represent changes from baseline in erection hardness on a scale of 1 to 4.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Patient must be age 16 or older
  • Patient must have a degenerative disease or inflammatory disease that meets criteria for treatment under the IRB which includes: Arthritis, Auto-immune disease,COPD, Cardiomyopathy, Peyronies Disease,Interstitial Cystitis, Erectile Dysfunction, and Neurodegenerative disease such as Parkinsons, ALS, Neuropathy.
  • Patient must be healthy enough to tolerate a local anesthetic

Exclusion Criteria:

  • Patient must not have active cancer
  • Patient must not have active infection

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): NCT01953523


Locations
United States, California
California Stem Cell Treatment Center
Rancho Mirage, California, United States, 92270
Sponsors and Collaborators
Elliot Lander
Investigators
Principal Investigator: Mark H Berman, MD Cell surgical network

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elliot Lander, Medical Director, Cell Surgical Network Inc.
ClinicalTrials.gov Identifier: NCT01953523     History of Changes
Other Study ID Numbers: CSN111
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Finishing 1000 patient safety paper for peer review and publication.

Keywords provided by Elliot Lander, Cell Surgical Network Inc.:
erectile dysfunction
peyronies
interstitial cystitis
cardiomyopathy
emphysema
copd
arthritis
multiple sclerosis
parkinson's

Additional relevant MeSH terms:
Osteoarthritis
Cardiomyopathies
Erectile Dysfunction
Emphysema
Pulmonary Emphysema
Autoimmune Diseases
Neurodegenerative Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Heart Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Immune System Diseases
Nervous System Diseases