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Biocellular Regenerative Therapy
Stem Cell and Growth Factor Therapy for Osteoarthritis (GARM-MSK-ALD Trial)
N/A
Recruiting
Research Sponsored by Healeon Medical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented osteoarthritic inflammatory and/or degenerative changes in the joint or connective tissues of the knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist/hand, foot/ankle, or Plantar Fasciitis (PR)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 6 months, 1 year
Awards & highlights
GARM-MSK-ALD Trial Summary
This trial is studying a new way to treat osteoarthritis by using a person's own stem cells and growth factors.
Who is the study for?
This trial is for adults with documented osteoarthritis who can follow treatment and tracking instructions. They must have enough donor tissue for the procedure, understand the consent form, and not have any systemic disorders that would make the procedures unsafe. People with active cancer, infections, drug addiction or severe brain injuries, pregnant women, high dose steroid users within six months before treatment are excluded.Check my eligibility
What is being tested?
The study tests minimally invasive treatments using a patient's own stem cells plus HD-PRP to treat osteoarthritis without pharmaceuticals or traditional surgery. It compares different combinations of Tissue Stromal Vascular Fraction (tSVF), Cellular Stromal Vascular Fraction (cSVF), PRP Concentrate and saline solution in three arms.See study design
What are the potential side effects?
Potential side effects may include discomfort at extraction and injection sites, infection risk from injections, allergic reactions to components used during treatment like PRP concentrate or normal saline solution.
GARM-MSK-ALD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have documented arthritis or tissue degeneration in my knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist/hand, foot/ankle, or have Plantar Fasciitis.
GARM-MSK-ALD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 6 months, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 6 months, 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes from Baseline visual analog pain scale (VAS)
Changes in Ultrasound Images from Baseline Condition
Numeric Pain Rating Scale (NPRS)
+1 moreSecondary outcome measures
Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Foot and Ankle Ability Measure (FAAM)
Foot and Ankle Disability Index (FADI)
+4 moreGARM-MSK-ALD Trial Design
3Treatment groups
Experimental Treatment
Group I: tSVF + PRP Arm1Experimental Treatment2 Interventions
Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate
Group II: tSVF + PRP + cSVF Arm 2Experimental Treatment3 Interventions
Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate + Cellular Stromal Vascular Fraction (cSVF)
Group III: Normal Saline IV + cSVF Arm 3Experimental Treatment2 Interventions
Cellular Stromal Vascular Fraction (cSVF); Sterile Normal Saline Intravenous (IV) Introduction
Find a Location
Who is running the clinical trial?
Healeon Medical IncLead Sponsor
8 Previous Clinical Trials
610 Total Patients Enrolled
Donna Alderman, DOUNKNOWN
Robert W. Alexander, MDUNKNOWN
3 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently dealing with drug addiction or in rehab.I have enough healthy tissue for donation.I do not have any infections that could make treatment risky for me.You have had serious brain injuries in the past.I can follow treatment and post-treatment instructions.I have not used high dose steroids or received corticosteroids in the last 6 months.I am currently receiving treatment for active cancer.I have documented arthritis or tissue degeneration in my knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist/hand, foot/ankle, or have Plantar Fasciitis.I have enough healthy tissue for donation.You have a condition that makes it difficult for you to understand and tolerate the procedures and follow-up requirements of the study.
Research Study Groups:
This trial has the following groups:- Group 1: tSVF + PRP Arm1
- Group 2: tSVF + PRP + cSVF Arm 2
- Group 3: Normal Saline IV + cSVF Arm 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04238143 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are my characteristics compatible with the criteria to participate in this experiment?
"For this osteoarthritis research project, 100 individuals aged 18 to 90 are being sought. Candidates must be free of systemic disorders which could jeopardise their safety; have ample donor tissue around their blood vessels and extracellular matrixes; and possess the maturity necessary to abide by treatment plans as well as fulfil post-treatment tracking requirements."
Answered by AI
Is this clinical trial actively enrolling participants?
"Confirmed, this medical study is still seeking participants. It has been listed on clinicaltrials.gov since January 10th 2020 and was last revised in April of 2022."
Answered by AI
What outcomes is this medical research attempting to demonstrate?
"The primary aim of this research is to evaluate the effect of Participant with Complications over Baseline, 6 months and 1 year. Secondary goals encompass assessing Foot and Ankle Disability Index (FADI) for changes in disability caused by pain and function; Knee Injury & Osteoarthritis Outcome Score (KOOS) determining knee health through gauging levels of pain from osteoarthritis; as well as Foot & Ankle Ability Measure (FAAM), which monitors shifts in discomfort, range-of-motion, and performance."
Answered by AI
Is there an age limit to participation in this experiment?
"This research protocol is open to any individuals aged 18 and below 90."
Answered by AI
How many people have enrolled in this medical experiment?
"Yes, the pertinent data hosted on clinicaltrials.gov confirms that recruitment for this medical study is ongoing. The information was initially posted on October 1st 2020 and most recently updated on April 7th 2022. This experiment necessitates the enrolment of 100 individuals at two distinct sites."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Arizona
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Regenevita LLC
Hemwall Center for Orthopedic Regenerative Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
Prolong a shoulder replacement. arthritis of both knees confirmed
arthritis of left shoulder confirmed.
PatientReceived no prior treatments
I once three years ago was about to have a knee replacement, but the anesthesiologist failed to find the afib in the preop exam and when I got to the OR the surgeon would not procede. I lost my faith in that surgeon and hospital, and have since been waiting for some new treatment to try.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long would I be in Montana each time?
PatientReceived 1 prior treatment
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