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

Trial Summary

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.

What data supports the effectiveness of the treatment Wharton's Jelly Allograft for back pain?

Wharton's jelly-derived mesenchymal stem cells (WJ-MSCs) have shown potential in regenerative medicine due to their ability to repair various tissues, as they can grow and transform into different cell types. However, there is a reported case of a patient developing arthritis after receiving a Wharton's jelly injection for back pain, highlighting the need for more research to ensure safety and effectiveness. ^{1 2 3 4 5}

Is Wharton's Jelly injection safe for humans?

There are some safety concerns with Wharton's Jelly injections. One case reported a man developing arthritis symptoms shortly after receiving an injection for back pain. However, another study on knee osteoarthritis found no adverse effects over three months. More research is needed to fully understand the safety of these injections. ^{1 2 3 6 7}

What makes Wharton's Jelly Allograft treatment unique for back pain?

Wharton's Jelly Allograft is unique because it uses stem cells derived from the umbilical cord, which have high regenerative potential and can differentiate into various cell types, making them promising for tissue repair. This treatment is different from traditional options as it leverages the regenerative properties of these cells, which are easily harvested and considered ethical to use. ^{2 3 4 8 9}

What is the purpose of this trial?

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 evaluated in 100 participants suffering with low back pain.

Research Team

James Faber, BA

Principal Investigator

Institute of Cellular and Regenerative Medicine IRB

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Isolation and expansion of mesenchymal stromal/stem cells from umbilical cord under chemically defined conditions. [2018]

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

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

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

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

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

Regenerative potential of Wharton's jelly-derived mesenchymal stem cells: A new horizon of stem cell therapy. [2021]

5. England 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. [2019]

6. England 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. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

8. England 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Discarded Wharton jelly of the human umbilical cord: a viable source for mesenchymal stromal cells. [2018]