Wharton's Jelly Injections for Back Pain

Recruiting at 3 trial locations

Overseen By Alexandre Scheer, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: R3 Stem Cell

Must not be taking: Pain medications, NSAIDs, Anticoagulants, Immunosuppressives

Disqualifiers: Autoimmune disorders, Carcinoma, Neurological, 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 week

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for chronic low back pain using injections of Wharton's Jelly, a substance derived from umbilical cords. The main goal is to determine the safety of these injections and their potential to alleviate back pain. Individuals with long-term back pain who have not recently undergone back surgery or received injections may qualify for this study. Participants must attend study visits and adhere to guidelines, such as avoiding pain medication immediately before joining. As a 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?

You must 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 lumbar symptom modifying drugs during the study with the clinical investigator.

Is there any evidence suggesting that Wharton's Jelly Allograft is likely to be safe for humans?

In earlier studies, Wharton's Jelly allograft demonstrated promising safety results. Research shows that patients who received these injections for knee osteoarthritis did not experience severe side effects. Another study on shoulder injuries found the treatment well-tolerated, with no major problems reported. Although this trial is still in the early stages, previous findings suggest that Wharton's Jelly allograft might be safe for humans. However, since this is a new treatment for back pain, the trial will gather more specific safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Wharton's Jelly allograft for back pain because it offers a regenerative approach that differs from standard treatments like pain medications, physical therapy, and steroid injections. Wharton's Jelly contains unique components from the umbilical cord that may help repair damaged tissues and reduce inflammation naturally. This treatment could provide longer-lasting relief by addressing the underlying issues rather than just masking symptoms, potentially improving patients' quality of life more effectively than conventional methods.

What evidence suggests that Wharton's Jelly Allograft might be an effective treatment for low back pain?

Research has shown that Wharton's Jelly, a gel-like substance from the umbilical cord, might help with back pain. This trial will investigate the effectiveness of lumbar injections with Wharton's Jelly Allograft for back pain relief. Studies have found that Wharton's Jelly can reduce pain in conditions like shoulder injuries and hip problems by improving patient outcomes. This suggests it might also help with low back pain. The jelly contains special cells that aid in healing and tissue repair. Early results are promising, but more research is needed to confirm its effectiveness specifically for back pain. ^{1 2 6 7 8}

Who Is on the Research Team?

James Faber, BA

Principal Investigator

Institute of Cellular and Regenerative Medicine IRB

Are You a Good Fit for This Trial?

This trial is for individuals experiencing low back pain. To participate, there are no specific inclusion criteria provided, but participants will likely need to meet certain health standards as determined by the study's protocol.

Inclusion Criteria

I am willing and able to give consent in English.

I am a woman who is not currently able to become pregnant.

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

Exclusion Criteria

I haven't had any lumbar spine injections in the last 6 months.

I have not been diagnosed with cancer in the last 5 years.

I am not taking any immunosuppressive medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lumbar injections with 10cc's of Umbilical Cord Wharton's Jelly Allograft

1 week

1 visit (in-person)

Follow-up

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

1 year

Multiple visits at 1 week, 6 weeks, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Wharton's Jelly Allograft

Trial Overview The trial is testing the safety and feasibility of injecting 10cc's of Wharton's Jelly Allograft into the lumbar (lower back) region in people with back pain. It’s an open-label and non-controlled pilot study involving 100 participants.

How Is the Trial Designed?

Group I: Lumbar Injection Arm Experimental Treatment 1 Intervention

Lumbar Injections with 10cc's of Umbilical Cord Wharton's Jelly Allograft (BelloWJY)

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

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

• Orthopedic pain
• Soft tissue defects
• Osteoarthritis

Who Is Running the Clinical Trial?

R3 Stem Cell

Lead Sponsor

Trials

3

Recruited

5,300+

R3 Medical Research

Industry Sponsor

Trials

2

Recruited

220+

Published Research Related to This Trial

Wharton's jelly-derived mesenchymal stem cells (WJ-MSCs) showed higher proliferative potential compared to bone marrow-derived MSCs (BM-MSCs), likely due to differences in gene expression related to cell proliferation and cycle regulation.

However, WJ-MSCs had lower capacity for differentiation into bone and fat cells and supported hematopoiesis less effectively than BM-MSCs, indicating that while they proliferate well, their functional applications may be limited without additional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential expression of cell cycle and WNT pathway-related genes accounts for differences in the growth and differentiation potential of Wharton's jelly and bone marrow-derived mesenchymal stem cells. Batsali, AK., Pontikoglou, C., Koutroulakis, D., et al.[2019]

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]

Umbilical cord Wharton's jelly-derived mesenchymal stem cells (WJ-MSCs) are promising for regenerative medicine due to their high proliferation rate, ability to differentiate into various cell types, and easy collection, making them suitable for treating a variety of tissue injuries.

WJ-MSCs have shown potential in clinical trials for regenerating tissues in conditions affecting the nervous system, heart, skin, liver, kidneys, cartilage, bone, and muscle, highlighting their versatility in therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative potential of Wharton's jelly-derived mesenchymal stem cells: A new horizon of stem cell therapy. Abbaszadeh, H., Ghorbani, F., Derakhshani, M., et al.[2021]

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]

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]

Isolating mesenchymal stromal/stem cells (MSC) from umbilical cord Wharton's Jelly is a promising alternative to using bone marrow aspirates, especially since MSC from adult donors have lower proliferation capacity.

The described protocol for MSC isolation from umbilical cords is easy, cost-effective, and reproducible, making it suitable for obtaining MSC from young healthy donors for use in allogeneic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolation and expansion of mesenchymal stromal/stem cells from umbilical cord under chemically defined conditions. Badraiq, H., Devito, L., Ilic, D.[2018]

In a phase I/II study involving 22 patients with type 2 diabetes mellitus (T2DM), transplantation of Wharton's Jelly-derived mesenchymal stem cells (WJ-MSCs) significantly improved metabolic control by lowering glucose and glycated hemoglobin levels, enhancing C-peptide levels, and improving beta cell function over a 12-month follow-up period.

The treatment was found to be safe, with no major adverse events reported, although a temporary decrease in C-peptide and beta cell function was observed one month post-treatment, likely due to the method of administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary evaluation of efficacy and safety of Wharton's jelly mesenchymal stem cell transplantation in patients with type 2 diabetes mellitus. Liu, X., Zheng, P., Wang, X., et al.[2022]

Wharton's Jelly (WJ) Mesenchymal Stromal Cells (MSC) can successfully differentiate into bone-forming cells when exposed to the right physiological bone environment, showing comparable osteogenic potential to bone marrow-derived MSCs (MSC,BM) in both in vitro and in vivo studies.

In vivo experiments demonstrated that 62.5% of mice treated with MSC,WJ showed successful bone formation without any adverse effects, indicating that MSC,WJ could be a safe and effective allogeneic therapy for bone repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Wharton's jelly-derived mesenchymal stromal cells promote bone formation in immunodeficient mice when administered into a bone microenvironment. Cabrera-Pérez, R., Ràfols-Mitjans, A., Roig-Molina, Á., et al.[2023]

Mesenchymal stromal cells (MSCs) from Wharton jelly (WJ) of the umbilical cord are a promising source for regenerative medicine due to their ability to differentiate into various cell types and their retention of primitive stemness properties.

WJ-MSCs are easier to harvest than other sources like bone marrow, making them an ethical and practical option for transplantation therapy in treating various debilitating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discarded Wharton jelly of the human umbilical cord: a viable source for mesenchymal stromal cells. Watson, N., Divers, R., Kedar, R., et al.[2018]

Citations

1. trialx.com trialx.com/clinical-trials/listings/287644/safety-and-feasibility-of-umbilical-cord-whartons-jelly-allograft-injections-for-lumbar-pain/?&radius=10&place=All%20Participating%20Sites&user_country=Germany

Safety and Feasibility of Umbilical Cord Wharton's Jelly ... Clinical trial for Low Back Pain , Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11048385/

Safety and Efficacy of Wharton's Jelly Connective Tissue ... The overall objective of this study is to evaluate the improvement of patient-reported pain scales after applying Wharton's Jelly (WJ) in rotator cuff defects.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8618385/

Umbilical Cord-Derived Wharton's Jelly for Regenerative ... This review reports the clinical and functional outcomes of the applications of WJSCs in orthopedic surgery.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0753332225007644

Wharton's jelly mesenchymal stem cells (WJ-MSCs), a “ ... Wharton's jelly, a gel-like connective tissue found in the umbilical cord, has emerged as a prominent source of stem cells for regenerative medicine and tissue ...

5. 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.

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06361485/

Trial | NCT06361485 This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be ...

7. 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.

8. healio.com healio.com/news/orthopedics/20240813/human-umbilical-cord-tissue-allograft-may-treat-cartilage-degeneration-hip-oa

Human umbilical cord tissue allograft may treat cartilage ... Key takeaways: Wharton's jelly tissue allografts, which are made from human umbilical cord tissue, may improve outcomes for hip osteoarthritis.