Clinical trial NCT01953523: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neurodegenerative Diseases
Osteoarthritis
Erectile Dysfunction
Autoimmune Diseases
Cardiomyopathies
Emphysema
Keywords: erectile dysfunction
peyronies
interstitial cystitis
cardiomyopathy
emphysema
copd
arthritis
multiple sclerosis
parkinson's
Lead sponsor: Cell Surgical Network Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 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 outcomes:
measure: Changes in the Oswestry Disability Index
timeFrame: 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.
measure: Changes in the Neck Disability Index
timeFrame: 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.
measure: Changes in Koos Physical Function Shortform
timeFrame: 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.
measure: Changes in Hoos Physical Function Shortform
timeFrame: 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.
measure: Changes in the DASH questionnaire
timeFrame: 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.
measure: Changes in the Visual Analog Pain Score
timeFrame: 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.
measure: Changes in the Aqol-4
timeFrame: 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.
measure: Changes in the O'leary-Sant IC Questionnaire
timeFrame: 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.
measure: Changes in PUF Symptom Scale
timeFrame: 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.
measure: Changes in the IIEF Questionnaire
timeFrame: 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.
measure: EHGS Grading Score measuring change in hardness score
timeFrame: 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.
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: California Stem Cell Treatment Center
state: California
Study officials:
affiliation: Cell surgical network
name: Mark H Berman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.