NCT01739504

Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra- Articularly in Patients With Osteoarthritis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Ageless Regenerative Institute · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly to affected joints. The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Osteoarthritis.

Detailed description

AD-SVF will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of AD-SVF. In addition, patient's peripheral blood will be collected for isolation of platelet rich plasma (PRP), which are then combined with the AD-SVF for intra-articular administration of affected joint.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Liposuction with Local Anesthesia	Liposuction under tumescent anesthesia for adipose tissue harvesting.
BIOLOGICAL	Intra articular infusion of AD-SVF	Adipose tissue is available in most patients for harvest through minimally invasive procedures such as liposuction. AD-SVF can be obtained in large quantities after processing of adipose tissue in the laboratory. * AD-SVF to promote tissue regeneration and repair with their ability to secrete various growth factors that can modulate host tissue environment. * Patient's AD-SVF combined with PRP are used for direct intra-articular injection after processing.

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2012-12-03
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States