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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01739504
• Other study ID #: AD-US-OR-001
• Status: Terminated
• Phase: N/A
• First received: September 28, 2012
• Last updated: November 21, 2017
• Start date: March 1, 2014
• Est. completion date: April 1, 2017

Study information

• Verified date: September 2016
• Source: Ageless Regenerative Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Ageless Institute LLC	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ageless Regenerative Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from Baseline of Quality of life scores		3 months, and 6 months
Primary	Change from Baseline of Reduction in analgesics		Baseline, 3 months, 6 months
Primary	Number of adverse events reported		6 months
Secondary	Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.		6 months