Alocyte for Back Pain

Overseen By Alimorad Farshchian, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alimorad Farshchian

Must not be taking: Anticoagulants, NSAIDs, Narcotics, Corticosteroids

Disqualifiers: Surgical intervention, Severe stenosis, Rheumatologic disorders, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 month

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Alocyte (Cord Blood Plasma Plus Mononucleic Cells) to determine its safety and effectiveness in reducing inflammation and relieving back pain from facet joints (the joints between the bones of the spine). Participants will receive varying doses of Alocyte to identify the most effective amount. The trial seeks individuals with chronic back pain lasting at least 6 months, particularly if it worsens with certain movements and has not improved with other treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as anticoagulants, NSAIDs, chronic narcotics, and corticosteroids, before and during the study. If you're on any of these, you may need to stop them for a specific period before participating.

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

Research shows that Alocyte, derived from cord blood plasma and certain blood cells, is under study to determine its safety for humans. Some studies have found that treatments like Alocyte can cause temporary backaches and symptoms similar to headaches and neck stiffness. In most cases, these effects were mild and resolved on their own.

Since Alocyte is in an early study phase, researchers are still gathering basic safety information. They are proceeding with caution, focusing primarily on its safety for people. So far, no clear evidence of serious problems has emerged, but more data is needed to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike traditional treatments for back pain, which often involve oral medications or surgeries, Alocyte offers a novel approach by being directly injected into the facet joints. Researchers are excited because Alocyte provides a more targeted treatment, potentially reducing the inflammation and pain right at the source. This direct injection method could minimize systemic side effects commonly associated with oral pain medications. Additionally, the different dosing options being explored—low, medium, and high doses—allow for tailored treatment to meet individual patient needs, which is something current standard treatments don't typically offer.

What evidence suggests that this trial's treatments could be effective for back pain?

Research has shown that Alocyte, a treatment derived from cord blood plasma and certain cells, might reduce inflammation and ease back pain caused by facet joints. This trial will test various doses of Alocyte—low, medium, and high—to evaluate its effectiveness. Although specific data on Alocyte remains limited, similar treatments like platelet-rich plasma have significantly reduced pain when injected into lower back joints. This suggests Alocyte could have a similar effect. Early studies in related areas indicate that Alocyte might improve pain and movement, but more research is needed to confirm these effects specifically for Alocyte. ^{1 2 4 6 7}

Who Is on the Research Team?

Alimorad Farshchian, MD

Principal Investigator

The Center For Regenerative Medicine Laboratories

Are You a Good Fit for This Trial?

This trial is for men and women over 18 with chronic back pain from facet joint issues, who've tried other treatments without success. They must be able to attend follow-ups and use contraception if of childbearing potential. Exclusions include severe diseases like cancer, liver or kidney disease, heart failure, bleeding disorders, recent other trials or treatments for back pain.

Inclusion Criteria

My back pain is diagnosed as facetogenic.

I have up to 5 affected facet joints.

I have had back pain for over 6 months and treatments haven't worked.

Exclusion Criteria

I do not have any uncontrolled health conditions like high blood pressure or severe asthma.

My MRI shows severe narrowing in my lower back.

I have severe chronic kidney disease or need dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Alocyte injections in facet joints at low, medium, or high doses

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person) at 1, 3, 6, and 12 months

Extension

Participants may continue to be monitored for long-term safety and efficacy

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Alocyte

Trial Overview The study tests Alocyte at three different doses to see if it's safe and can reduce inflammation or relieve chronic back pain caused by facet joint degeneration. It involves injecting a combination of cord blood plasma and cells into the affected area.

How Is the Trial Designed?

Group I: Alocyte Medium dose Experimental Treatment 1 Intervention

Subjects will receive medium dose injections in three facet joints

Group II: Alocyte Low dose Experimental Treatment 1 Intervention

Subjects will receive low dose injection in a single facet joint

Group III: Alocyte High dose Experimental Treatment 1 Intervention

Subjects will receive high dose injections in five facet joints

Who Is Running the Clinical Trial?

Alimorad Farshchian

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

The study evaluated the effectiveness of elutriation in isolating monocytes and lymphocytes from 59 clinical PBMC concentrates, demonstrating that this method consistently separates these cells for use in therapies.

While elutriation effectively isolated monocytes and lymphocytes, additional processing steps were necessary to reduce neutrophil contamination and improve the quality of the final cell products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counter-flow elutriation of clinical peripheral blood mononuclear cell concentrates for the production of dendritic and T cell therapies. Stroncek, DF., Fellowes, V., Pham, C., et al.[2021]

Umbilical cord blood transplantation has proven effective for treating various diseases, including blood cancers and metabolic disorders, and can be safely cryopreserved for future use.

Cord blood offers advantages over other donor sources, such as a lower risk of graft-vs.-host disease and infection transmission, making it a promising option for both transplantation and potential regenerative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cord blood transplantation and stem cell regenerative potential. Liao, Y., Geyer, MB., Yang, AJ., et al.[2011]

Cord blood (CB) serum contains different soluble factors compared to adult serum, which significantly affects T cell function, showing that T cell proliferation is enhanced by adult serum but not by CB serum when stimulated through the T cell receptor.

Macrophage colony stimulating factor (M-CSF) is present in CB serum but absent in adult serum, suggesting it may act as a suppressor factor in CB serum, potentially explaining the reduced immune response in fetuses and the lower incidence of graft-versus-host disease in stem cell transplants using CB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macrophage colony stimulating factor (M-CSF) within cord blood sera may be partially responsible for the reduced proliferation of cord blood T cells. Cohen, SB., Woolley, J., Bogunia-Kubik, K., et al.[2006]

Umbilical cord blood (UCB) contains valuable multipotential cells that can be used for treating various diseases and injuries, offering a safe and effective alternative to bone marrow for blood lineage reconstitution.

Research shows that UCB can provide therapeutic benefits in animal models for conditions like stroke, heart attacks, and neurodegenerative diseases, and it can be easily collected and stored without harm to the mother or infant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Umbilical cord blood cells. Newcomb, JD., Willing, AE., Sanberg, PR.[2015]

Cord blood (CB) plasma significantly enhances the expansion of hematopoietic progenitor cells, increasing colony-forming unit (CFU) yields by 2.23-fold, especially when the ABO blood types are unmatched.

In contrast, adult peripheral blood plasma does not promote the expansion of these progenitor cells, suggesting that specific factors in CB plasma could be beneficial for stem cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cord blood plasma selectively stimulates the expansion of hematopoietic pregenitor cells in vitro]. Wu, G., Ying, D., Lin, Z., et al.[2004]

Ex vivo expansion (EvE) of cryopreserved cord blood mononuclear cells (MNCs) for up to 7 days significantly increases the number of natural killer (NK) cells and enhances their tumor-killing abilities, making them more effective for potential immunotherapy.

The study found that this 7-day EvE process not only boosts NK cell populations but also enriches specific subsets of NK-like T (NKT) cells, while increasing the production of key cytokines like IL-18 and interferon-gamma, which are important for immune responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of natural killer and natural killer-like T cells derived from ex vivo expanded and activated cord blood mononuclear cells: implications for adoptive cellular immunotherapy. Ayello, J., van de Ven, C., Cairo, E., et al.[2021]

In a study of 540 peripheral progenitor cell (PPC) collections over 7 years, nearly 20% of collections experienced patient-related side effects, primarily paresthesias due to citrate toxicity, which were effectively managed with calcium supplementation.

Technical issues, including problems with venous access and blood cell separators, occurred in about 10% of collections, highlighting the need for careful monitoring during the apheresis procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in peripheral progenitor cell collection: a 7-year experience. Moog, R.[2004]

The Milan Cord Blood Bank successfully banked 763 units of cord blood by 1995, with 8 units used for transplants in both children and adults, demonstrating the potential of cord blood in hematopoietic stem cell transplantation.

Early cord clamping after delivery was found to significantly increase the volume of cord blood collected without harming the newborn, and using 3% gelatin as a sedimenting agent yielded the best concentration of progenitor cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Milan Cord Blood Bank and the Italian Cord Blood Network. Lazzari, L., Corsini, C., Curioni, C., et al.[2006]

Using fresh human cord blood, researchers successfully maintained long-term growth of normal, immature myeloid cells, which required specific conditions like hydrocortisone and continuous agitation.

In contrast, leukocytes from EBV-seronegative adult blood allowed for the sustained culture of pure populations of monocytes and macrophages for over 5 months, providing a valuable resource for studying these cells in both healthy and disease contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of long-term monocyte suspension cultures from normal human peripheral blood. Salahuddin, SZ., Markham, PD., Gallo, RC.[2019]

In a study involving 49 patients with non-haematopoietic degenerative conditions, the use of unmatched allogeneic umbilical cord blood mononuclear cells (CBMNCs) showed no major adverse effects, indicating a promising safety profile for this treatment approach.

No acute adverse effects or graft-versus-host disease (GVHD) were observed, suggesting that low-dose administration of unmatched CBMNCs could be a safe therapeutic option for patients lacking HLA-matched donors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety in using unmatched allogeneic umbilical cord blood mononuclear cells transplantations in non-haematopoietic degenerative conditions. Vyas, R., Dudhat, D., Navik, P., et al.[2015]

The IBM 2991 blood cell processor effectively concentrates mononuclear cells from large volumes of bone marrow, achieving an average recovery rate of 78.3% for mononuclear cells and 67.5% for CFU-GM across 22 samples.

The procedure maintains high cell viability, with 97.1% of cells being viable, which is crucial for ensuring the quality of bone marrow for procedures like autologous grafts or allogeneic bone marrow transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Method for concentrating marrow stem cells using the IBM 2991 washer. Necessary preparation before in vitro treatment of bone marrow by pharmacologic or immunologic means]. Hervé, P., Coffe, C., Peters, A.[2019]

The study demonstrated that it is feasible and safe to collect and infuse fresh autologous umbilical cord blood (UCB) cells in neonates with hypoxic-ischemic encephalopathy (HIE), with no significant changes in vital signs post-infusion.

Among the infants who received UCB cells, 74% had favorable 1-year survival outcomes with developmental scores above 85, compared to 41% in a control group, suggesting potential benefits of UCB cell therapy in improving long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy. Cotten, CM., Murtha, AP., Goldberg, RN., et al.[2022]

Only 25% of collected cord blood units met the storage criteria, primarily due to insufficient volume, delayed processing, and low cell counts, highlighting the need for improved collection and processing methods.

Transplanted cord blood units had significantly higher cell counts compared to stored units and were more frequently sourced from ethnic minority groups, indicating that both cell quality and donor diversity are important for successful transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mannheim Cord Blood Bank: Experiences and Perspectives for the Future. Lauber, S., Latta, M., Klüter, H., et al.[2021]

Using a two-round density gradient centrifugation (2-r FDGC) method significantly improves the purification of umbilical cord blood mononuclear cells (CB MNCs), increasing the percentage of lymphocyte subsets and natural killer (NK) activity compared to the conventional one-round method (1-r FDGC).

The enhanced NK activity observed in CB MNCs after 2-r FDGC suggests that this method is more effective for preparing samples for flow cytometric analysis and NK cytotoxicity assays, while not affecting the lymphocyte subsets in adult peripheral blood MNCs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of two-round Ficoll-Hypaque density gradient centrifugation on lymphocyte subsets and natural killer activity of umbilical cord blood mononuclear cells. Yang, MH., Lin, SJ.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05909709

NCT05909709 | Dose Escalation Pilot Study to Evaluate ... The purpose of this study is to see if the use of Alocyte (cord blood plasma plus mononucleic cells) will be safe, well tolerated, and whether it causes any ...

2. withpower.com withpower.com/trial/phase-1-arthralgia-6-2023-66ec5

Alocyte for Back Pain · Recruiting Participants for Phase ... Trial Overview The study tests Alocyte at three different doses to see if it's safe and can reduce inflammation or relieve chronic back pain caused by facet ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05909709/dose-escalation-pilot-study-to-evaluate-the-safety-of-alocyte-for-the-treatment-of-facetogenic-back-pain

Dose Escalation Pilot Study to Evaluate the Safety of ... The purpose of this study is to see if the use of Alocyte (cord blood plasma plus mononucleic cells) will be safe, well tolerated, and whether it causes any ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352341/

Platelet Rich Plasma for the Therapy of the Lumbar Facet ... found that PRP injections into lumbar facet joints significantly reduced pain and improved functional outcomes compared to steroid injections.

5. policylab.us policylab.us/clinical-trials/l/conditions/back-pain

Back Pain Clinical Trials - Policy Lab A listing of 11 Back Pain clinical trials actively recruiting volunteers for paid trials and research studies in various therapeutic areas.

6. clinicaltrial.be clinicaltrial.be/fr/details/285145?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Dose Escalation Pilot Study to Evaluate the Safety of Alo... An open label dose escalation pilot study to evaluate the safety of Alocyte delivered via intra-articular facet injection for the treatment of facetogenic back ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11061649/

Adverse events of cell therapy clinical trials in human chronic ... The most common adverse events were transient backache and meningism (90%) and cord malacia (80%). The cell therapy method in which the treatment was associated ...