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

NCT01953523 | Completed DMC

• 1 other identifier: CSN111
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Diseases; Osteoarthritis; Erectile Dysfunction; Autoimmune Diseases; Cardiomyopathies; Emphysema

Keywords

erectile dysfunction; peyronies; interstitial cystitis; cardiomyopathy; emphysema; copd; arthritis; multiple sclerosis; parkinson's

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes in the Oswestry Disability Index

  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

  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

  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

  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

  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.

Study Arms (1)

Deployment of stromal vascular fraction

EXPERIMENTAL

Administration of autologous adipose derived SVF

Procedure: Administration of autologous adipose derived SVF

Interventions

Administration of autologous adipose derived SVF PROCEDURE

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

Deployment of stromal vascular fraction

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient must not have active cancer
• Patient must not have active infection

Sponsors & Collaborators

• Elliot Lander: lead

Study Sites (1)

California Stem Cell Treatment Center

Rancho Mirage, California, 92270, United States

Location

Related Publications (1)

• 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.

  PMID: 25974235 DERIVED

Related Links

• cell surgical network

MeSH Terms

Conditions

Neurodegenerative Diseases; Osteoarthritis; Erectile Dysfunction; Autoimmune Diseases; Cardiomyopathies; Emphysema; Cystitis, Interstitial; Pulmonary Disease, Chronic Obstructive; Arthritis; Multiple Sclerosis; Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark H Berman, MD

  Cell surgical network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: October 1, 2013
• Study Start: September 2, 2013
• Primary Completion: December 31, 2016
• Study Completion: January 1, 2017
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)