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

Not Applicable

Terminated

• Conditions: Osteoarthritis
• Interventions: Procedure: Liposuction with Local Anesthesia; Biological: Intra articular infusion of AD-SVF

• Registration Number: NCT01739504
• Lead Sponsor: Ageless Regenerative Institute

Brief 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.

Study Timeline

• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-03
• Study Start: 2014-03-01
• Status Verified: 2016-09
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Males and Females between Age 18 and 80 years.
• Patient with current proven diagnosis of Osteoarthritis, with consistent symptomatology
• Up to date on all age and gender appropriate cancer screening per American Cancer Society.

Exclusion Criteria

• Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study.
• Life expectancy < 6 months due to concomitant illnesses.
• Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
• Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status
• Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
• Patients on chronic immunosuppressive transplant therapy
• Systolic blood pressure (supine) ≤90 mm Hg or greater than 180mmHg
• Resting heart rate > 100 bpm;
• Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
• History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
• Active clinical infection
• Unwilling and/or not able to give written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Adipose-derived Stromal Vascular Fraction infusion	Liposuction with Local Anesthesia	Intervention: AD-SVF infusion directly into affected joints.
Autologous Adipose-derived Stromal Vascular Fraction infusion	Intra articular infusion of AD-SVF	Intervention: AD-SVF infusion directly into affected joints.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Visual Analogue Scale (VAS)	3 months, 6 months	For pain score, functional rating index, visual analog scale (VAS), physical therapy (PT), and range of motion (ROM) were determined as previously described. The patient was restricted from taking steroids, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) for one week prior to the procedure.
Number of adverse events reported	6 months
Change from Baseline of Quality of life scores	3 months, and 6 months
Change from Baseline of Reduction in analgesics	Baseline, 3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.	6 months

Trial Locations

Locations (1)

Ageless Institute LLC; 🇺🇸 Aventura, Florida, United States