NCT03390920

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jan 2022Jan 2030

First Submitted

Initial submission to the registry

December 19, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
4 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

December 19, 2017

Last Update Submit

September 10, 2021

Conditions

OsteoarthritisTendinitisSports InjuryDegenerative Disc DiseaseDegenerative ArthritisLigament InjuryNeuropathyPelvic Pain

Keywords

regenerative medicinearthritisamnioticstem cellgrowth factorcartilage

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Work Status

    Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year

  • Visual Analog Scale (VAS)

    Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year

Study Arms (1)

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.

Other: Umbilical Allograft

Interventions

Umbilical AllograftOTHER

The umbilical allograft is regulated by the FDA and comes from a lab that is FDA registered.

Umbilical Allograft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and over.
  • Ability to attend follow up visits or at least converse on phone or complete email follow up forms.
  • \) Competent to understand the study protocol and provide voluntary informed consent.

You may not qualify if:

  • Active Infection
  • Pregnancy, Lactating
  • Clotting disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Stem Cell Institute

Encino, California, 91316, United States

Location

Related Publications (5)

  • 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.

    PMID: 16784908RESULT

  • 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.

    PMID: 19699503RESULT

  • 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.

    PMID: 17141065RESULT

  • 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.

    PMID: 18038420RESULT

  • 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.

    PMID: 17206138RESULT

MeSH Terms

Conditions

OsteoarthritisTendinopathyAthletic InjuriesIntervertebral Disc DegenerationPelvic PainArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMuscular DiseasesTendon InjuriesWounds and InjuriesSpinal DiseasesBone DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

David Greene, PhD, MBA

CONTACT

844-438-7836dgreene@r3stemcell.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

January 4, 2018

Study Start

January 1, 2022

Primary Completion

January 1, 2025

Study Completion (Estimated)

January 1, 2030

Last Updated

September 17, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations

US(1)