Wharton's Jelly Injections for Knee Osteoarthritis

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: R3 Medical Research

Must not be taking: NSAIDs, Anticoagulants, Immunosuppressives, others

Disqualifiers: Autoimmune disorders, Carcinoma, Knee infection, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using Wharton's Jelly, a substance from umbilical cords, to help people with knee osteoarthritis. The goal is to determine if injections of this jelly are safe and effective in reducing knee pain. Participants will receive one of three different doses to identify the most effective amount. Individuals with moderate knee osteoarthritis and significant knee pain may be suitable for this study. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires that you stop taking any pain medications, including NSAIDs, at least 2 weeks before the study injection. You also need to discuss and report any use of knee-symptom modifying drugs during the study with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that injections of umbilical cord Wharton's Jelly (WJ) are under study for safety in treating knee osteoarthritis. Some studies have examined WJ injections for reducing knee pain and improving movement. So far, these studies have not identified any serious safety issues.

However, as this trial is in an early stage, researchers continue to gather safety information. They monitor how well participants tolerate the treatment and watch for any side effects. This phase often marks the first time the treatment is tested in humans.

The trial tests different treatment doses, with participants receiving either a low, medium, or high dose. While previous studies have assessed the safety of WJ injections, this study will clarify how different doses impact safety.

In summary, early research on WJ injections appears promising for safety, but this trial will provide more detailed information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Wharton's Jelly injections are unique because they use a natural substance derived from umbilical cords, potentially offering a regenerative approach to treating knee osteoarthritis. Unlike standard treatments like NSAIDs or corticosteroids, which primarily manage symptoms, Wharton's Jelly may help repair damaged tissues. Researchers are especially excited about its potential to reduce inflammation and promote healing directly at the site of injury, with varying doses (2cc, 3cc, and 4cc) to tailor the treatment to patient needs. This innovative approach could offer relief and improved joint function beyond what current therapies provide.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Studies have shown that injecting Wharton's Jelly, a substance from the umbilical cord, into the knee may help reduce osteoarthritis symptoms. This trial will administer different doses of Wharton's Jelly Allograft—2cc, 3cc, or 4cc—to evaluate its effectiveness. Research indicates that patients who received these injections reported less pain and improved joint movement. Wharton's Jelly contains natural substances that might protect and repair joint cartilage. Early findings suggest it could be a promising option for managing knee osteoarthritis symptoms. However, further research is needed to confirm these initial results. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis who are interested in trying a new treatment involving injections. Participants will be chosen randomly to receive one of three different doses of the injection.

Inclusion Criteria

Be willing and capable of giving written informed consent to participate in English

I am not pregnant, using birth control, and do not plan to become pregnant during the study.

My knee has moderate to severe arthritis.

Exclusion Criteria

Injury or disability claims under current litigation or pending or approved workers compensation claims

I had knee surgery within the last 6 months.

I have not had any knee injections in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one intra-articular knee injection containing either low, medium, or high dose Wharton's Jelly allograft tissue

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, pain relief, and functional improvements

1 year

Visits at 1 week, 6 weeks, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Umbilical Cord Wharton's Jelly Allograft

Trial Overview The study is testing the safety and how well people can tolerate Wharton's Jelly (WJ) allograft tissue injected into the knee at low, medium, or high doses. It's an early-stage trial to see if this could be a feasible treatment for osteoarthritis.

How Is the Trial Designed?

Group I: 2cc WJ Allograft (Low Dose) Active Control 1 Intervention

The 2cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Low Dose Group.

Group II: 3cc WJ Allograft (Medium Dose) Active Control 1 Intervention

The 3cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Medium Dose Group.

Group III: 4cc WJ Allograft (High Dose) Active Control 1 Intervention

The 4cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the High Dose Group.

Umbilical Cord Wharton's Jelly Allograft is already approved in United States for the following indications:

Approved in United States as Wharton's Jelly Allograft for:

• Knee osteoarthritis

Who Is Running the Clinical Trial?

R3 Medical Research

Lead Sponsor

Trials

2

Recruited

220+

Published Research Related to This Trial

This study will evaluate the safety and efficacy of umbilical cord-derived Wharton's jelly (WJ) injections for treating knee osteoarthritis (OA) symptoms in 168 participants over one year, comparing it to hyaluronic acid and saline controls.

The research aims to provide new treatment options for patients with grade II/III knee OA, potentially enhancing current therapies and improving patient outcomes based on various assessment tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of umbilical cord-derived Wharton's jelly compared to hyaluronic acid and saline for knee osteoarthritis: study protocol for a randomized, controlled, single-blind, multi-center trial. Gupta, A., Maffulli, N., Rodriguez, HC., et al.[2021]

Porcine Wharton's jelly cells (WJCs) can be effectively administered via intraperitoneal injection and are found to distribute widely throughout various organs in immune-competent allogeneic hosts, including the intestines, liver, and spleen.

The study suggests that these cells may play a role in the gastrointestinal tract, potentially acting as endogenous stem cells and providing therapeutic secretions to help repair tissue damaged by intestinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Porcine Wharton's jelly cells distribute throughout the body after intraperitoneal injection. Packthongsuk, K., Rathbun, T., Troyer, D., et al.[2018]

A 27-year-old male with grade II knee osteoarthritis showed a 50% reduction in pain immediately after receiving a 2 mL injection of umbilical cord-derived Wharton's jelly, with significant improvements in overall knee function and quality of life at 3 months follow-up.

No adverse effects were reported from the injection, and there was no progression of osteoarthritis observed on X-rays, suggesting that UC-derived WJ may be a safe treatment option for knee OA, although further studies are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Knee Osteoarthritis with Intraarticular Umbilical Cord-Derived Wharton's Jelly: A Case Report. Gupta, A., Rodriguez, HC., Potty, AG., et al.[2021]

Intra-articular injections of mesenchymal stem cells derived from Wharton jelly in 10 patients with knee osteoarthritis led to significant pain reduction and functional improvement over a 1-year follow-up, as measured by various clinical scales.

MRI results showed increased cartilage thickness in most regions, supporting the efficacy of the treatment, while changes in inflammatory markers like adiponectin and leptin in synovial fluid indicated a positive biochemical response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of clinical, biochemical, and radiological outcomes following intra-articular injection of Wharton jelly-derived mesenchymal stromal cells in patients with knee osteoarthritis: A prospective clinical study. Günay, AE., Karaman, I., Guney, A., et al.[2022]

This study will evaluate the safety and efficacy of intraarticular injections of umbilical cord-derived Wharton's Jelly (UC-derived WJ) in 12 patients with grade II/III knee osteoarthritis, focusing on improvements in pain and function over a follow-up period of 1 year.

The research aims to provide valuable data on UC-derived WJ, which contains regenerative factors, and will help inform future larger trials by assessing various outcomes like pain relief and cartilage regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Umbilical cord-derived Wharton's jelly for treatment of knee osteoarthritis: study protocol for a non-randomized, open-label, multi-center trial. Gupta, A., Maffulli, N., Rodriguez, HC., et al.[2022]

A 36-year-old man developed HLA-B27-associated reactive arthritis within 24 hours of receiving a Wharton's jelly stem cell injection for low back pain, indicating potential risks associated with these treatments.

This case underscores the need for caution regarding the use of allogenic gestational tissue-derived products, as they may pose unknown dangers and require further study and regulation to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of HLA-B27-Associated Reactive Arthritis After a Wharton's Jelly "Stem Cell" Injection. Madhoun, H., Landry, K., Baria, MR.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8165766/

Safety and efficacy of umbilical cord-derived Wharton's jelly ... The proposed study aims to evaluate the safety and efficacy of intra-articular injection of UC-derived WJ for the treatment of knee OA symptoms.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06608134

Safety and Feasibility of Umbilical Cord Wharton's Jelly ... This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular ...

3. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-021-02300-0

Umbilical cord-derived Wharton's jelly for treatment of knee ... The proposed study evaluates the safety and efficacy of intraarticular injection of UC-derived WJ for treatment of knee OA symptoms.

4. mdpi.com mdpi.com/2077-0383/13/14/4040

Retrospective Evaluation of Cryopreserved Human ... This study presents changes in reported pain scales from patients who received Wharton's jelly applications to cartilage deterioration in the hip.

5. withpower.com withpower.com/trial/early-phase-1-osteoarthritis-9-2024-d44aa

Wharton's Jelly Injections for Knee Osteoarthritis What data supports the effectiveness of the treatment Umbilical Cord Wharton's Jelly Allograft for knee osteoarthritis? Research shows that injections of ...

6. ctv.veeva.com ctv.veeva.com/study/safety-and-feasibility-of-umbilical-cord-whartons-jelly-allograft-injections-for-knee-osteoarthriti

Safety and Feasibility of Umbilical Cord Wharton's Jelly ... This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34059080/

Safety and efficacy of umbilical cord-derived Wharton's jelly ... The proposed study aims to evaluate the safety and efficacy of intra-articular injection of UC-derived WJ for the treatment of knee OA symptoms.