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NCT04238143 · ClinicalTrials.gov registry record · NA

Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

A NA study of Osteoarthritis and Osteo Arthritis Knee, sponsored by Healeon Medical.

Recruiting
Registry status
NA
Development phase
100
Enrollment target
2
Study locations

NCT04238143 is a NA study of Osteoarthritis and Osteo Arthritis Knee that is actively recruiting participants, run by Healeon Medical. The registered enrollment target is 100 participants, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04238143, a NA study of Osteoarthritis and Osteo Arthritis Knee, is actively recruiting participants, sponsored by Healeon Medical.

RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
2
Study locations

Study Summary

Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical interventions have not yielded convincing long-term outcomes, including total joint replacement surgeries and medical management of the supportive structures. This study is to use a person's own stem/stromal Cells (autologous) plus HD-PRP (important healing growth factors and signal molecules) in such cases of OA for long-term minimally invasive treatments. Baseline (existing) findings are documented, and thence tracked as to progress deemed to be result of the intervention.

Interventions

  • PROCEDURE Tissue Stromal Vascular Fraction (tSVF) Arm 1
  • BIOLOGICAL PRP Concentrate Arm 1
  • PROCEDURE Tissue Stromal Vascular Fraction (tSVF) Arm 2
  • BIOLOGICAL PRP Concentrate Arm 2
  • PROCEDURE Cellular Stromal Vascular Fraction (cSVF) Arm 2

Study Locations (2)

California

  • Hemwall Center for Orthopedic Regenerative Medicine - Valencia

Montana

  • Regenevita LLC - Stevensville

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2020-01-10
Est. Completion 2027-09-30
Phase NA

Sponsor

Healeon Medical

1 total trials

What the Registry Record Tells You About NCT04238143

The ClinicalTrials.gov registry entry for NCT04238143 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (88% lower). The listed sponsor is Healeon Medical, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Osteoarthritis appearing as the primary indexed condition, and to 5 interventions - of which Tissue Stromal Vascular Fraction (tSVF) Arm 1 is the first listed.

NCT04238143 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Montana.

Frequently Asked Questions

What is clinical trial NCT04238143 about?

NCT04238143 is a clinical study titled "Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis". Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical intervention...

What is the current status of trial NCT04238143?

This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2020-01-10. Estimated completion is 2027-09-30.

What conditions does trial NCT04238143 study?

This clinical trial studies the following conditions: Osteoarthritis, Osteo Arthritis Knee, Osteoarthritis, Hip, Osteo Arthritis Shoulders, Osteoarthritis of Multiple Joints.

What interventions are being tested in trial NCT04238143?

The interventions under investigation include: Tissue Stromal Vascular Fraction (tSVF) Arm 1 (PROCEDURE), PRP Concentrate Arm 1 (BIOLOGICAL), Tissue Stromal Vascular Fraction (tSVF) Arm 2 (PROCEDURE), PRP Concentrate Arm 2 (BIOLOGICAL), Cellular Stromal Vascular Fraction (cSVF) Arm 2 (PROCEDURE).

Who is sponsoring clinical trial NCT04238143?

This trial is sponsored by Healeon Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04238143 being conducted?

This trial has 2 study locations across California, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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