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

Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953523
• Other study ID #: CSN111
• Status: Completed
• Phase: N/A
• Start date: September 2, 2013
• Est. completion date: January 1, 2017

Study information

• Verified date: September 2018
• Source: Cell Surgical Network Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: January 1, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Cardiomyopathies
• Emphysema
• Erectile Dysfunction
• Neurodegenerative Diseases
• Osteoarthritis
• Pulmonary Emphysema

Intervention

Procedure:
• Administration of autologous adipose derived SVF
Intra-venous, intra-articular, and soft tissue injection delivery of SVF

Locations

Country	Name	City	State
United States	California Stem Cell Treatment Center	Rancho Mirage	California

Sponsors (1)

Lead Sponsor	Collaborator
Elliot Lander

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   cell surgical network