Umbilical Cord Allograft for Musculoskeletal Pain/Injuries

Recruiting at 1 trial location

Overseen By David Greene, PhD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: R3 Stem Cell

Disqualifiers: Active infection, Pregnancy, Clotting disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Immediate intervention

200 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{4 5 6 7 8}

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. ^{1 4 5 9 10}

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.

Eligibility Criteria

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.

Exclusion Criteria

Lactating

Pregnancy

I have a blood clotting disorder.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Umbilical Allograft Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

R3 Stem Cell

Lead Sponsor

Trials

3

Recruited

5,300+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Allogenic Perinatal Tissue for Musculoskeletal Regenerative Medicine Applications: A Systematic Review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Implantation of cryopreserved umbilical cord allograft in hard-to-heal foot wounds: a retrospective study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

An Open-label, Single-center, Retrospective Study of Cryopreserved Amniotic Membrane and Umbilical Cord Tissue as an Adjunct for Foot and Ankle Surgery. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Allogenic Umbilical Cord Tissue for Treatment of Knee Osteoarthritis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Injectable Amniotic Membrane/Umbilical Cord Particulate for Knee Osteoarthritis: A Prospective, Single-Center Pilot Study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Successful treatment of painful chronic wounds with amniotic and umbilical cord tissue: A case series. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Safety analysis of cryopreserved amniotic membrane/umbilical cord tissue in foot and ankle surgery: a consecutive case series of 124 patients. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Amniotic membrane and/or umbilical cord tissue for treatment of facet joint syndrome: a narrative review. [2023]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Stem cells from umbilical cord and placenta for musculoskeletal tissue engineering. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Allogenic Umbilical Cord Tissue as a Scaffold for Ankle Osteoarthritis. [2023]