200 Participants Needed

Umbilical Cord Allograft for Musculoskeletal Pain/Injuries

Recruiting at 1 trial location
DG
DG
Overseen ByDavid Greene, PhD, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: R3 Stem Cell
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is umbilical cord allograft safe for treating musculoskeletal pain or injuries?

Research shows that using umbilical cord tissue for various conditions, like knee osteoarthritis and chronic wounds, is generally safe. Studies report no serious side effects, and any minor complications were resolved successfully.12345

How is the umbilical cord allograft treatment different from other treatments for musculoskeletal pain or injuries?

The umbilical cord allograft treatment is unique because it uses perinatal tissues, which include growth factors and stem cells, to potentially regenerate damaged musculoskeletal tissues. Unlike traditional treatments, it does not require invasive procedures to harvest cells and avoids ethical concerns associated with embryonic stem cells.15678

What data supports the effectiveness of the treatment Amniotic, Umbilical Allograft for musculoskeletal pain or injuries?

Research shows that using umbilical cord tissue in treatments can reduce pain by 50% and improve knee function in osteoarthritis patients. Additionally, patients undergoing foot and ankle surgeries with similar treatments reported significant pain reduction and better functional outcomes.158910

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I understand the study details and agree to participate voluntarily.
I understand the study details and agree to participate.
I can attend follow-up visits or communicate via phone or email.
See 1 more

Exclusion Criteria

Lactating
Pregnancy
I have a blood clotting disorder.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an amniotic fluid tissue product for pain relief and functional improvements

Immediate intervention
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at 4 weeks, 3 months, 6 months, 9 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Amniotic
  • Umbilical Allograft
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

R3 Stem Cell

Lead Sponsor

Trials
3
Recruited
5,300+

Citations

Allogenic Perinatal Tissue for Musculoskeletal Regenerative Medicine Applications: A Systematic Review. [2022]
Implantation of cryopreserved umbilical cord allograft in hard-to-heal foot wounds: a retrospective study. [2022]
An Open-label, Single-center, Retrospective Study of Cryopreserved Amniotic Membrane and Umbilical Cord Tissue as an Adjunct for Foot and Ankle Surgery. [2019]
Allogenic Umbilical Cord Tissue for Treatment of Knee Osteoarthritis. [2022]
Injectable Amniotic Membrane/Umbilical Cord Particulate for Knee Osteoarthritis: A Prospective, Single-Center Pilot Study. [2020]
Successful treatment of painful chronic wounds with amniotic and umbilical cord tissue: A case series. [2020]
Safety analysis of cryopreserved amniotic membrane/umbilical cord tissue in foot and ankle surgery: a consecutive case series of 124 patients. [2019]
Amniotic membrane and/or umbilical cord tissue for treatment of facet joint syndrome: a narrative review. [2023]
9.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Stem cells from umbilical cord and placenta for musculoskeletal tissue engineering. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Allogenic Umbilical Cord Tissue as a Scaffold for Ankle Osteoarthritis. [2023]
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