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The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions. The study is prospective, with outcome measures being obtained at numerous time points after the regenerative procedure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Allograft | Experimental | The study is nonrandomized with one arm. Depending on the body area being treated, the amount of the product utilized will be either 1.0cc's or 2cc's. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Allograft | Other | The umbilical allograft is regulated by the FDA and comes from a lab that is FDA registered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short Musculoskeletal Function Assessment Questionnaire (SMFA) | 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. | Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year |
| Measure | Description | Time Frame |
|---|---|---|
| Work Status | Not Working, Part Time, Full Time, Retired | Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year |
| Visual Analog Scale (VAS) | Assesses pain based on a scale from 0 to 100 |
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Inclusion Criteria:
4) Competent to understand the study protocol and provide voluntary informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Greene, PhD, MBA | Contact | 844-438-7836 | dgreene@r3stemcell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Stem Cell Institute | Encino | California | 91316 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16784908 | Result | Aagaard-Tillery KM, Silver R, Dalton J. Immunology of normal pregnancy. Semin Fetal Neonatal Med. 2006 Oct;11(5):279-95. doi: 10.1016/j.siny.2006.04.003. Epub 2006 Jun 19. | |
| 19699503 | Result | Shay E, Kheirkhah A, Liang L, Sheha H, Gregory DG, Tseng SC. Amniotic membrane transplantation as a new therapy for the acute ocular manifestations of Stevens-Johnson syndrome and toxic epidermal necrolysis. Surv Ophthalmol. 2009 Nov-Dec;54(6):686-96. doi: 10.1016/j.survophthal.2009.03.004. Epub 2009 Aug 21. |
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De-identified individual participant data for all outcome measures will be made available.
Data will be available within six months of study completion.
Solutions IRB is overseeing the study and will review data access requests.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 25, 2017 | Dec 19, 2017 |
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| Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year |
| 17141065 | Result | Delo DM, De Coppi P, Bartsch G Jr, Atala A. Amniotic fluid and placental stem cells. Methods Enzymol. 2006;419:426-38. doi: 10.1016/S0076-6879(06)19017-5. |
| 18038420 | Result | Soncini M, Vertua E, Gibelli L, Zorzi F, Denegri M, Albertini A, Wengler GS, Parolini O. Isolation and characterization of mesenchymal cells from human fetal membranes. J Tissue Eng Regen Med. 2007 Jul-Aug;1(4):296-305. doi: 10.1002/term.40. |
| 17206138 | Result | De Coppi P, Bartsch G Jr, Siddiqui MM, Xu T, Santos CC, Perin L, Mostoslavsky G, Serre AC, Snyder EY, Yoo JJ, Furth ME, Soker S, Atala A. Isolation of amniotic stem cell lines with potential for therapy. Nat Biotechnol. 2007 Jan;25(1):100-6. doi: 10.1038/nbt1274. Epub 2007 Jan 7. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D052256 | Tendinopathy |
| D001265 | Athletic Injuries |
| D055959 | Intervertebral Disc Degeneration |
| D017699 | Pelvic Pain |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009135 | Muscular Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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