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

Primary Purpose

Neurodegenerative Diseases, Osteoarthritis, Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Administration of autologous adipose derived SVF
Sponsored by
Elliot Lander
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurodegenerative Diseases focused on measuring erectile dysfunction, peyronies, interstitial cystitis, cardiomyopathy, emphysema, copd, arthritis, multiple sclerosis, parkinson's

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • California Stem Cell Treatment Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deployment of stromal vascular fraction

Arm Description

Administration of autologous adipose derived SVF

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.

Full Information

First Posted
September 2, 2013
Last Updated
September 21, 2018
Sponsor
Elliot Lander
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1. Study Identification

Unique Protocol Identification Number
NCT01953523
Brief Title
Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2, 2013 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elliot Lander

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodegenerative Diseases, Osteoarthritis, Erectile Dysfunction, Autoimmune Diseases, Cardiomyopathies, Emphysema
Keywords
erectile dysfunction, peyronies, interstitial cystitis, cardiomyopathy, emphysema, copd, arthritis, multiple sclerosis, parkinson's

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deployment of stromal vascular fraction
Arm Type
Experimental
Arm Description
Administration of autologous adipose derived SVF
Intervention Type
Procedure
Intervention Name(s)
Administration of autologous adipose derived SVF
Intervention Description
Intra-venous, intra-articular, and soft tissue injection delivery of SVF
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
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.
Secondary Outcome Measure Information:
Title
Changes in the Oswestry Disability Index
Description
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.
Title
Changes in the Neck Disability Index
Description
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.
Title
Changes in Koos Physical Function Shortform
Description
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.
Title
Changes in Hoos Physical Function Shortform
Description
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.
Title
Changes in the DASH questionnaire
Description
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.
Title
Changes in the Visual Analog Pain Score
Description
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.
Title
Changes in the Aqol-4
Description
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.
Title
Changes in the O'leary-Sant IC Questionnaire
Description
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.
Title
Changes in PUF Symptom Scale
Description
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.
Title
Changes in the IIEF Questionnaire
Description
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.
Title
EHGS Grading Score measuring change in hardness score
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark H Berman, MD
Organizational Affiliation
Cell surgical network
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Stem Cell Treatment Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Finishing 1000 patient safety paper for peer review and publication.
Citations:
PubMed Identifier
25974235
Citation
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.
Results Reference
derived
Links:
URL
http://www.stemcellrevolution.com
Description
cell surgical network

Learn more about this trial

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

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