Umbilical Cord Allograft for Musculoskeletal Pain/Injuries

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether an amniotic fluid tissue product (also known as an umbilical allograft) can relieve pain and improve function in people with musculoskeletal issues, such as joint pain or muscle injuries. The trial involves a regenerative procedure and measures outcomes at various intervals. It suits adults who can attend follow-up visits or communicate via phone or email. Participants must understand the study and provide consent. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatments for musculoskeletal issues.

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 prior data suggests that this treatment is safe for musculoskeletal conditions?

Research has shown that using umbilical cord tissue for conditions like knee arthritis and chronic wounds is generally safe, with studies reporting no major safety concerns.

In another study, football players with muscle or tendon tears received injections of amniotic membrane and umbilical cord tissue. The treatment proved safe and facilitated a quick return to play.

Additionally, another study supported the safe use of amniotic membrane and umbilical cord treatments for back pain, suggesting that patients tolerate the treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for musculoskeletal pain, which often include physical therapy, anti-inflammatory medications, or steroid injections, umbilical cord allografts offer a regenerative approach. This treatment uses cells derived from umbilical cords, which have the potential to promote healing and tissue regeneration. Researchers are excited about this because it could lead to faster recovery and longer-lasting relief compared to conventional methods. Plus, the non-invasive injection method allows for targeted delivery right to the affected area, potentially minimizing side effects and maximizing effectiveness.

What evidence suggests that this treatment might be an effective treatment for musculoskeletal conditions?

Research has shown that using umbilical cord tissue, the focus of this trial, can greatly reduce pain and improve movement in people with osteoarthritis, a common joint problem. One study found that this treatment could lower pain by 50% and enhance knee function. Other studies support these findings, showing overall improvements in pain relief, movement, and quality of life for people with various muscle and joint issues. Although this trial specifically investigates umbilical cord tissue, amniotic tissue products have also shown promise in treating injuries to tendons, ligaments, and cartilage. Several studies indicate noticeable improvements in pain and daily activities within 24 to 36 weeks after treatment. ^{1 3 5 6 7}

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.

Exclusion Criteria

Lactating

Pregnancy

I have a blood clotting disorder.

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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9767063/

Clinical Outcomes of Amniotic Membrane/Umbilical Cord ... This study provides additional evidence for the safe use of amniotic membrane/umbilical cord (AMUC) particulate in the treatment of back pain.

2. withpower.com withpower.com/trial/phase-tendinopathy-2022-2270f

Umbilical Cord Allograft for Musculoskeletal Pain/Injuries Research shows that using umbilical cord tissue in treatments can reduce pain by 50% and improve knee function in osteoarthritis patients. Additionally, ...

3. journals.lww.com journals.lww.com/ajpmr/fulltext/2025/06000/effectiveness_of_amnion_allograft_injections_in.11.aspx

Effectiveness of Amnion Allograft Injections in Patients... Results indicated that amnion allograft injections produced significant pain reduction, functional improvement, and quality of life enhancement in patients ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138324006302

The use of amniotic tissue-derived products in orthopedic ... These products have shown promising preclinical and early clinical results in the treatment of tendon/ligament injuries, cartilage defects, and osteoarthritis.

5. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39624&ver=3&keyword=amniotic%20and%20placental%20derived&keywordType=starts&areaId=s27&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1

Amniotic and Placental Derived Product Injections and/or ... Intermediate outcomes obtained at 24-36 weeks post-injection showed clinically relevant improvement in pain reduction and functional activities. The mean ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03390920?term=AREA%5BBasicSearch%5D(tendonitis%20and%20stem%20cell%20treatment)&rank=4

Evaluation of Outcomes With Umbilical Cord Allograft for ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11611701/

Injection of Amniotic Membrane and Umbilical Cord ... Injection of AM/UC powder is a safe treatment that enables quick return to play in this cohort of football players suffering from muscle or tendon tears.