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

Elliot Lander

Status: Completed

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

Treatments: Procedure: Administration of autologous adipose derived SVF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01953523

CSN111

Details and patient eligibility

About

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.

Full description

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

Enrollment: 3,000 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,000 participants in 1 patient group

Deployment of stromal vascular fraction

Experimental group

Description:

Administration of autologous adipose derived SVF

Treatment:

Procedure: Administration of autologous adipose derived SVF