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

NCT01739504 | Terminated

• 1 other identifier: AD-US-OR-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Arthritis; Joint pain; Articular cartilage; Mesenchymal stem cells; Autologous; Adipose tissue

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Visual Analogue Scale (VAS)

  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.

  3 months, 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

• Number of adverse events reported

  6 months

Secondary Outcomes (1)

• Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.

  6 months

Study Arms (1)

Autologous Adipose-derived Stromal Vascular Fraction infusion

EXPERIMENTAL

Intervention: AD-SVF infusion directly into affected joints.

Procedure: Liposuction with Local Anesthesia; Biological: Intra articular infusion of AD-SVF

Interventions

Liposuction with Local Anesthesia PROCEDURE

Liposuction under tumescent anesthesia for adipose tissue harvesting.

Also known as: Lipoplasty, Liposculpture, Suction-assisted fat removal

Autologous Adipose-derived Stromal Vascular Fraction infusion

Intra articular infusion of AD-SVF BIOLOGICAL

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.

Autologous Adipose-derived Stromal Vascular Fraction infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ageless Regenerative Institute: lead

Study Sites (1)

Ageless Institute LLC

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Arthralgia

Interventions

Lipectomy; Anesthesia, Local

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Sharon McQuillan, MD

  Ageless Regenerative Institute

  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

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: December 3, 2012
• Study Start: March 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: November 24, 2017

Record last verified: 2016-09

Locations

US (1)