Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis
This study is currently recruiting participants.
Verified November 2012 by Ageless Regenerative Institute
Sponsor:
Ageless Regenerative Institute
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT01739504
First received: September 28, 2012
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stem Cell (ASC) 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.
ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. In addition,peripheral blood will be collected for isolation of platelet rich plasma.
The adipose tissue is transferred to the laboratory for separation of the adipose tissue derived stem cells, which are then transferred for intra-articular administration in the patient's platelet rich plasma.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Procedure: Liposuction and intra-articular injection Other: Joint Injection |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ageless Regenerative Institute:
Primary Outcome Measures:
- Change from Baseline in Visual Analogue Scale (VAS) [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
- Change from Baseline of Quality of life scores [ Time Frame: 3 months, and 6 months ] [ Designated as safety issue: No ]
- Change from Baseline of Reduction in analgesics [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- number of adverse events reported [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from Baseline in x-ray of affected joint [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: stem cell injection |
Procedure: Liposuction and intra-articular injection
Other Names:
Other: Joint Injection
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient with current proven diagnosis of Osteoarthritis, with consistent symptomotology
- 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 mmHg 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739504
Contacts
| Contact: Kristin Comella | 855-274-2355 | kcomella@agelessregen.com |
Locations
| United States, Florida | |
| Ageless Institute | Recruiting |
| Aventura, Florida, United States, 33180 | |
| Contact: Janny Garcia, BS 305-933-2988 jgarcia@agelessregen.com | |
Sponsors and Collaborators
Ageless Regenerative Institute
More Information
No publications provided
| Responsible Party: | Ageless Regenerative Institute |
| ClinicalTrials.gov Identifier: | NCT01739504 History of Changes |
| Other Study ID Numbers: | ADI-US-OR-001 |
| Study First Received: | September 28, 2012 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ageless Regenerative Institute:
|
arthritis joint pain |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013