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

Not Applicable

Not yet recruiting

• Conditions: Tendinitis; Degenerative Arthritis; Osteoarthritis; Sports Injury; Degenerative Disc Disease; Ligament Injury; Pelvic Pain; Neuropathy
• Interventions: Other: Umbilical Allograft

• Registration Number: NCT03390920
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-04
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17
• Study Start: 2022-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Umbilical Allograft	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.

Primary Outcome Measures

Name	Time	Method
Short Musculoskeletal Function Assessment Questionnaire (SMFA)	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

Name	Time	Method
Work Status	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)	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

Trial Locations

Locations (1)

Advanced Stem Cell Institute; 🇺🇸 Encino, California, United States