Trial record 8 of 1033 for:    Open Studies | "Neurodegenerative Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Cell Surgical Network Inc.
Sponsor:
Information provided by (Responsible Party):
Elliot Lander, Cell Surgical Network Inc.
ClinicalTrials.gov Identifier:
NCT01953523
First received: September 2, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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 Intervention
Neurodegenerative Diseases
Osteoarthritis
Erectile Dysfunction
Autoimmune Diseases
Cardiomyopathies
Emphysema
Procedure: Administration of autologous adipose derived SVF

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Cell Surgical Network Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    Outcome measures will include the number of participants with adverse events related to either SVF deployment or the lipo-harvesting procedure.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Changes in the Oswestry Disability Index Score will be measured. Outcomes represent changes from baseline in symptom and abilities scores on 11 questions.

  • 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. ] [ Designated as safety issue: No ]
    Changes in the Neck Disability Index Score will be measured. Outcomes represent changes from baseline in symptom and abilities scores on 10 questions.

  • 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. ] [ Designated as safety issue: No ]
    Changes in Koos Physical Function Shortform will be measured. Outcomes represent changes in level of function score from none to extreme.

  • 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. ] [ Designated as safety issue: No ]
    Changes in Hoos Physical Function Shortform will be measured. Outcomes represent changes in level of function score from none to extreme.

  • 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. ] [ Designated as safety issue: No ]
    Changes in the DASH Questionnaire Score will be measured. Outcomes represent changes from baseline in symptoms and abilities scores on 11 questions.

  • 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. ] [ Designated as safety issue: No ]
    Changes in the Visual Analog Pain Score will be measured. Outcomes represent changes from baseline from none to severe.

  • 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. ] [ Designated as safety issue: No ]
    Changes in the Aqol-4 Assessment of Quality of Life Instrument will be measured. Outcomes represent changes from baseline in 12 subjective scores.

  • 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. ] [ Designated as safety issue: No ]
    Changes in the O'leary-Sant IC Questionnaire will be measured. Outcomes represent changes from baseline in 8 symptom and problem scores

  • 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. ] [ Designated as safety issue: No ]
    Changes in the PUF Symptom Scale will be measured. Outcomes represent changes from baseline in in 8 symptom and bother scores.

  • 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. ] [ Designated as safety issue: No ]
    Changes in the IIEF Questionnaire Score will be measured. Outcomes represent changes in erectile function from baseline in 5 sexual function scores.

  • 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. ] [ Designated as safety issue: No ]
    Changes in the EHGS Grading Score will be measured. Outcomes represent changes from baseline in erection hardness on a scale of 1 to 4.


Estimated Enrollment: 3000
Study Start Date: March 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953523

Contacts
Contact: Elliot B Lander, MD 760-346-0145 info@cellsurgicalnetwork.com
Contact: Marlina Manchego 800-231-0407 marlina@cellsurgicalnetwork.com

Locations
United States, California
California Stem Cell Treatment Center Recruiting
Rancho Mirage, California, United States, 92270
Contact: Annette Pinuelas    800-231-0407    annette@cellsurgicalnetwork.com   
Contact: Marlina Manchego    760-346-0145    marlina@cellsurgicalnetwork.com   
Principal Investigator: Mark H Berman, MD         
Principal Investigator: Elliot B Lander, MD         
Sponsors and Collaborators
Elliot Lander
Investigators
Principal Investigator: Mark H Berman, MD Cell surgical network
  More Information

Additional Information:
No publications provided

Responsible Party: Elliot Lander, Medical Director, Cell Surgical Network Inc.
ClinicalTrials.gov Identifier: NCT01953523     History of Changes
Other Study ID Numbers: CSN111
Study First Received: September 2, 2013
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 20, 2014