Clinical trial NCT01739504: Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Keywords: Arthritis
Joint pain
Articular cartilage
Mesenchymal stem cells
Autologous
Adipose tissue
Lead sponsor: Ageless Regenerative Institute
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Visual Analogue Scale (VAS)
timeFrame: 3 months, 6 months
measure: Change from Baseline of Quality of life scores
timeFrame: 3 months, and 6 months
measure: Change from Baseline of Reduction in analgesics
timeFrame: Baseline, 3 months, 6 months
measure: Number of adverse events reported
timeFrame: 6 months
Secondary outcomes:
measure: Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.
timeFrame: 6 months
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Ageless Institute LLC
state: Florida
Study officials:
affiliation: Ageless Regenerative Institute
name: Sharon McQuillan, MD
role: PRINCIPAL_INVESTIGATOR
References: