Evaluation of Outcomes With Amniotic Fluid for Musculoskeletal Conditions Musculoskeletal Conditions
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|ClinicalTrials.gov Identifier: NCT03390920|
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Tendinitis Sports Injury Degenerative Disc Disease Degenerative Arthritis Ligament Injury Neuropathy Pelvic Pain||Biological: Amniotic||Phase 2 Phase 3|
Medical providers are often faced with patients whose source of pain may be the result of an inflammatory response caused by trauma or disease. By managing the patient's inflammation, the clinician may see improved response to traditional pain management therapy and existing protocols.
Also, degenerative arthritis of spinal and extremity joints may lead to significant low back, knee, hip, shoulder pain etc, as the ratio of cartilage degradation to cartilage formation increases with age. An amniotic tissue derived product may prove to be an ideal non-steroidal and potentially regenerative therapy for use by the medical provider due to its unique characteristics.
The orthopedic application of amniotic fluid dates back to at least the 1930's. The placental membranes produce an array of immunosuppressive and anti-inflammatory molecules, which make these tissues suitable for use as a wound covering [or as an anti-inflammatory] in a clinical setting. In addition to structural properties, placental membrane and amniotic fluid (AF) is a rich source of growth factors, including organic compounds and nutrients, hyaluronic acids, amino acids, antioxidants and stem cells.
AF's anti-inflammatory actions may be mediated in part by its secretion of anti-inflammatory cytokines including interleukin-10, inhibin, activin, and interleukin-1 receptor antagonist as well as anti-inflammatory protease inhibitors such as ∞-1 anti-trypsin inhibitor and inter-a-trypsin inhibitor. AF may modulate acquired immunity by suppressing alloreactive responses and down regulating production of Th1 and Th2 cytokines.
In addition to having known anti-inflammatory qualities, placental membrane cells, derived from the layer of trophoblast cells covering the developing embryo, do not express MHC Class II antigens, which are responsible for the rapid rejection of allografts in humans. Because AF is immune privileged, it is an ideal allograft with no known graft-versus-host disease (GVHD).
The amniotic fluid product may provide not only an anti-inflammatory response, but also potentially yield regenerative effect or reduce further cartilage degeneration.
The objective of this study is to evaluate an amniotic fluid tissue product in the treatment of pain due to all types of musculoskeletal conditions.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Regenerative Medicine Treatment Outcomes With Amniotic Fluid for Musculoskeletal Conditions|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2022|
The study is nonrandomized with one arm. Depending on the body area being treated, the amount of the amniotic product utilized will be either 0.5 cc's or 1.0cc's.
The amniotic product is regulated by the FDA as a biologic and comes from a lab that is FDA registered/certified.
- Short Musculoskeletal Function Assessment Questionnaire (SMFA) [ Time Frame: Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year ]The Short Musculoskeletal Function Assessment Questionnaire (SMFA) is designed to measure the functional status of patients with a broad range of musculoskeletal injuries and disorders.
- Work Status [ Time Frame: Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year ]Not Working, Part Time, Full Time, Retired
- Visual Analog Scale (VAS) [ Time Frame: Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year ]Assesses pain based on a scale from 0 to 100
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390920
|Contact: David Greene, MBAfirstname.lastname@example.org|
|United States, Nevada|
|Stem Cell Therapy of Las Vegas||Recruiting|
|Las Vegas, Nevada, United States, 89119|
|Contact: Lambert Abeyatunge, MD 702-483-3535 email@example.com|
|Principal Investigator: Lambert Abeyatunge, MD|