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

Trial Summary

What is the purpose of this trial?

This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.

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.

What data supports the effectiveness of the treatment Umbilical Cord Wharton's Jelly Allograft for knee osteoarthritis?

Research shows that injections of Wharton's Jelly from the umbilical cord can reduce pain and improve function in people with knee osteoarthritis. Patients reported less pain and better knee function after treatment, and some studies noted increased cartilage thickness, suggesting potential benefits for joint health. ^{1 2 3 4 5}

Is Wharton's Jelly injection safe for humans?

Some studies suggest that Wharton's Jelly injections for knee osteoarthritis are generally safe, with no adverse effects reported in certain cases. However, there has been a report of a serious reaction, including arthritis, after a Wharton's Jelly injection for back pain, indicating potential risks. More research is needed to fully understand the safety of these injections. ^{1 2 3 4 6}

How is the Wharton's Jelly Allograft treatment different from other treatments for knee osteoarthritis?

Wharton's Jelly Allograft is unique because it uses regenerative components from the umbilical cord, like growth factors and cytokines, to potentially repair knee cartilage, unlike traditional treatments that mainly focus on pain relief. ^{1 2 3 4 5}

Eligibility Criteria

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

I can follow the study's requirements and communicate in English.

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.

Exclusion Criteria

I had knee surgery within the last 6 months.

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

I am taking medications that suppress my immune system.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

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

Treatment of Knee Osteoarthritis with Intraarticular Umbilical Cord-Derived Wharton's Jelly: A Case Report. [2021]

2. United States 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. [2022]

3. England 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. [2022]

4. England 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. [2021]

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

Porcine Wharton's jelly cells distribute throughout the body after intraperitoneal injection. [2018]

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

Induction of HLA-B27-Associated Reactive Arthritis After a Wharton's Jelly "Stem Cell" Injection. [2021]