Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.
| Status: | Terminated |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 11/25/2017 |
| Start Date: | March 1, 2014 |
| End Date: | April 1, 2017 |
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
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.
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.
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.
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.
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.
We found this trial at
1
site
Aventura, Florida 33180
Principal Investigator: Sharon McQuillan, MD
Phone: 954-744-7400
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