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Completed

NCT Number: NCT01953523

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

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.

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Key information

Conditions

Neurodegenerative Diseases Arthritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Cardiomyopathies Cardiovascular Diseases Central Nervous System Diseases Chronic Disease Cystitis Cystitis, Interstitial Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Emphysema Erectile Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Heart Diseases Immune System Diseases Joint Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Mental Disorders Movement Disorders Multiple Sclerosis Musculoskeletal Diseases Nervous System Diseases Osteoarthritis Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Rheumatic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Synucleinopathies Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Stem Cell Treatment Center

Rancho Mirage, California, 92270, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of autologous adipose derived SVF

Procedure

Intra-venous, intra-articular, and soft tissue injection delivery of SVF

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Elliot Lander

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 1, 2013
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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