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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
Sponsor:
Information provided by (Responsible Party):
R3 Stem Cell

Brief Summary:
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.

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

Detailed Description:

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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Amniotic
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.
Biological: Amniotic
The amniotic product is regulated by the FDA as a biologic and comes from a lab that is FDA registered/certified.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 and over.
  2. Ability to attend follow up visits or at least converse on phone or complete email follow up forms.

4) Competent to understand the study protocol and provide voluntary informed consent.

Exclusion Criteria:

  1. Active Infection
  2. Pregnancy, Lactating
  3. Clotting disorder

Information from the National Library of Medicine

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


Contacts
Contact: David Greene, MBA 844-438-7836 dgreene@r3stemcell.com

Locations
United States, Nevada
Stem Cell Therapy of Las Vegas Recruiting
Las Vegas, Nevada, United States, 89119
Contact: Lambert Abeyatunge, MD    702-483-3535    info@r3stemcell.com   
Principal Investigator: Lambert Abeyatunge, MD         
Sponsors and Collaborators
R3 Stem Cell
  Study Documents (Full-Text)

Documents provided by R3 Stem Cell:
Informed Consent Form  [PDF] May 25, 2017


Additional Information:
Publications of Results:
Responsible Party: R3 Stem Cell
ClinicalTrials.gov Identifier: NCT03390920     History of Changes
Other Study ID Numbers: #2017/05/6
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available within six months of study completion.
Access Criteria: Solutions IRB is overseeing the study and will review data access requests.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by R3 Stem Cell:
regenerative medicine
arthritis
amniotic
stem cell
growth factor
cartilage

Additional relevant MeSH terms:
Wounds and Injuries
Arthritis
Osteoarthritis
Pelvic Pain
Intervertebral Disc Degeneration
Tendinopathy
Athletic Injuries
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Muscular Diseases
Tendon Injuries