What is the mechanism of action of this treatment?

Regenerative treatments for osteoarthritis, such as Platelet-Rich Plasma (PRP) and stem cell therapies, work by promoting tissue repair and reducing inflammation. PRP is derived from the patient's own blood and contains high concentrations of growth factors that stimulate cell proliferation and matrix synthesis, aiding in tissue regeneration. Stem cell therapies involve the use of mesenchymal stem cells that can differentiate into cartilage cells and release anti-inflammatory cytokines. These mechanisms are significant for OA patients as they address both pain and the underlying tissue damage, potentially improving joint function and quality of life.

What side effects are associated with this type of intervention?

Common treatments for osteoarthritis with regenerative properties, such as Platelet-Rich Plasma (PRP) and mesenchymal stem cell injections, generally have minor and transient side effects. These include pain, tenderness, swelling, and bruising at the injection site. There is also a risk of local infection associated with intraarticular injections. For other common treatments like NSAIDs, side effects can include gastrointestinal issues, cardiovascular risks, and renal complications. Intraarticular glucocorticoid injections may provide short-term pain relief but are not recommended for routine use due to potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, though many focus on symptom management rather than regenerative properties. Traditional treatments include NSAIDs for pain relief and corticosteroid injections for inflammation. Regenerative therapies, such as platelet-rich plasma (PRP) and mesenchymal stem cell (MSC) injections, are being investigated for their potential to promote tissue repair and reduce inflammation, but they are not yet widely approved by the FDA for osteoarthritis. These therapies aim to leverage the body's natural healing processes, though more research is needed to confirm their efficacy and safety.

What other types of research exist?

Promising alternatives to Amniotic Fluid Tissue Product for osteoarthritis treatment include: 1) Platelet-Rich Plasma (PRP), which has shown potential in improving pain and function in joint conditions; 2) Bone Marrow Concentrate, which is being investigated for its ability to regenerate cartilage; and 3) Mesenchymal Stem Cell Therapy, which is being explored for its regenerative properties and ability to reduce inflammation. These therapies are still under investigation, but they offer potential benefits for osteoarthritis patients.

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Regenerative Medicine

Umbilical Cord Allograft for Musculoskeletal Pain/Injuries

N/A

Waitlist Available

Research Sponsored by R3 Stem Cell

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 and over.

Competent to understand the study protocol and provide voluntary informed consent

Must not have

Clotting disorder

Active Infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and then assess changes post intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an amniotic fluid product to see if it can reduce pain and improve function in people with muscle and joint problems. The product uses natural substances found in amniotic fluid to reduce inflammation and possibly help heal tissues. It is aimed at patients who do not respond well to regular pain treatments.

Who is the study for?

This trial is for adults over 18 with various musculoskeletal conditions like pelvic pain, sports injuries, arthritis, and more. Participants must understand the study and consent to it, as well as commit to follow-up visits or remote check-ins. Pregnant or breastfeeding individuals, those with active infections or clotting disorders cannot join.

What is being tested?

The trial is testing an Amniotic Fluid Tissue Product (Umbilical Allograft) for relieving pain and improving function in musculoskeletal conditions. It's a forward-looking study that will measure outcomes at different times after the treatment.

What are the potential side effects?

While specific side effects are not listed here, similar treatments may cause injection site reactions, infection risk increase, allergic responses or no improvement in symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I understand the study details and agree to participate voluntarily.

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I am 18 years old or older.

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I understand the study details and agree to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood clotting disorder.

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I do not have any current infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and then assess changes post intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and then assess changes post intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and then assess changes post intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Short Musculoskeletal Function Assessment Questionnaire (SMFA)

Secondary study objectives

Visual Analog Scale (VAS)

Work Status

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Umbilical AllograftExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Regenerative treatments for osteoarthritis, such as Platelet-Rich Plasma (PRP) and stem cell therapies, work by promoting tissue repair and reducing inflammation. PRP is derived from the patient's own blood and contains high concentrations of growth factors that stimulate cell proliferation and matrix synthesis, aiding in tissue regeneration. Stem cell therapies involve the use of mesenchymal stem cells that can differentiate into cartilage cells and release anti-inflammatory cytokines. These mechanisms are significant for OA patients as they address both pain and the underlying tissue damage, potentially improving joint function and quality of life.

Stem Cells for the Treatment of Knee Osteoarthritis: A Comprehensive Review.