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Trial record 2 of 11 for:    r3 stem cell

Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03390920
Recruitment Status : Not yet recruiting
First Posted : January 4, 2018
Last Update Posted : September 17, 2021
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 Other: Umbilical Allograft Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Regenerative Medicine Outcomes With Umbilical Allograft for Musculoskeletal Conditions
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2030

Arm Intervention/treatment
Experimental: Umbilical Allograft
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.
Other: Umbilical Allograft
The umbilical allograft is regulated by the FDA and comes from a lab that is FDA registered.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03390920

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Contact: David Greene, PhD, MBA 844-438-7836

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United States, California
Advanced Stem Cell Institute
Encino, California, United States, 91316
Contact: David Greene, PhD    844-438-7836   
Sponsors and Collaborators
R3 Stem Cell
  Study Documents (Full-Text)

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

Publications of Results:
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Responsible Party: R3 Stem Cell Identifier: NCT03390920    
Other Study ID Numbers: #2017/05/6
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
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.

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Studies a U.S. FDA-regulated Drug Product: No
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
stem cell
growth factor
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Pelvic Pain
Wounds and Injuries
Athletic Injuries
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Muscular Diseases
Tendon Injuries