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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
Must not have
Medication or Opiate addition, or in active treatment for drug rehabilitation
Known active cancer, chemotherapy, or radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 6 months, 1 year
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently dealing with drug addiction or in rehab.
Select...
I am currently receiving treatment for active cancer.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes from Baseline visual analog pain scale (VAS)
Changes in Ultrasound Images from Baseline Condition
Numeric Pain Rating Scale (NPRS)
+1 moreSecondary study objectives
Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Foot and Ankle Ability Measure (FAAM)
Foot and Ankle Disability Index (FADI)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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