What side effects are associated with this type of intervention?

Common treatments for back pain with anti-inflammatory and regenerative properties, such as NSAIDs, corticosteroids, and biologic therapies, can have various side effects. NSAIDs may cause gastrointestinal issues, cardiovascular problems, and kidney damage. Corticosteroids can lead to weight gain, osteoporosis, and increased risk of infections. Biologic therapies, including stem cell treatments, may cause immune reactions, infections, and in some cases, complications related to the procedure itself. Alocyte, which involves cord blood plasma and mononucleic cells, is being studied for its safety and potential side effects, which are not yet fully known but may include similar risks associated with biologic treatments.

What prior FDA approvals exist?

The FDA has approved various treatments for back pain, primarily focusing on anti-inflammatory and pain relief properties. Commonly approved drugs include nonsteroidal anti-inflammatory drugs (NSAIDs) like naproxen and ibuprofen, which reduce inflammation and alleviate pain. Additionally, regenerative therapies such as platelet-rich plasma (PRP) injections have been explored for their potential to promote healing and reduce inflammation, although their use is often limited to clinical trials. While specific FDA approvals for treatments combining cord blood plasma and mononucleic cells like Alocyte are not detailed, the interest in regenerative medicine for back pain is evident in ongoing research and investigational studies.

What other types of research exist?

Promising alternatives to Alocyte for back pain treatment include: 1) Platelet-Rich Plasma (PRP) therapy, which has shown potential in reducing inflammation and promoting tissue regeneration in musculoskeletal injuries. 2) Mesenchymal Stem Cell (MSC) therapy, which has demonstrated efficacy in promoting healing and reducing inflammation in various conditions, including chronic wounds and musculoskeletal injuries. 3) Intra-articular injections of biologic agents like fibroblast growth factor-18 (FGF-18), which have shown promise in cartilage repair and could potentially be adapted for spinal disc regeneration.

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Cell Therapy

Alocyte for Back Pain

Phase 1

Recruiting

Led By Alimorad Farshchian, MD

Research Sponsored by Alimorad Farshchian

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Facetogenic back pain diagnosed using specific diagnostic criteria

Patient with up to 5 diseased facet joints

Must not have

Any unstable condition of clinical significance, e.g., uncontrolled hypertension, unstable angina pectoris, worsening asthma

MRI finding of severe high-grade lumbar stenosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 months, 6 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Alocyte, a treatment made from umbilical cord blood, on patients with back pain due to issues in their spine joints. Current treatments don't fix the underlying problem. Alocyte aims to reduce inflammation and help the body repair itself, potentially providing longer-lasting relief. Amniotic membrane and umbilical cord (AMUC) particulate may be useful in relieving pain and inhibiting the degenerative cascade in patients with discogenic pain by reducing inflammation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified but may include reactions at the injection site, general discomfort or worsening pain temporarily after treatment. The trial aims to assess safety so close monitoring for any adverse effects will occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My back pain is diagnosed as facetogenic.

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I have up to 5 affected facet joints.

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

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My MRI shows severe narrowing in my lower back.

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I have severe chronic kidney disease or need dialysis.

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I have had stem cell injections in the past year.

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My leg pain is worse than my back pain.

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I am a woman who could become pregnant and am not using birth control.

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I have severe heart failure or dangerous irregular heartbeats.

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I have had surgery for back pain before.

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I have HIV that has not been treated.

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I have severe breathing problems.

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I cannot stop my blood thinner medication before treatment.

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I have a history of liver disease or currently show signs of jaundice.

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I haven't taken hydroxychloroquine, steroids, or immune system modifiers in the last 21 days.

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My pain increases when I bend.

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I have a broken bone in my lower back.

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My BMI is over 42 kg/m2.

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I am on the transplant list or will be listed for an organ transplant.

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I have received a solid organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 months, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 months, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of treatment emergent adverse events as assessed by blood biomarker sample lab tests

Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests

Incidence of treatment emergent adverse events as assessed by safety coagulation panel lab tests

+3 more

Secondary study objectives

Efficacy of Alocyte Treatment for pain as assessed by the change in the Owestry Back Pain questionnaire

Efficacy of Alocyte Treatment for pain management as assessed by the change in Numeric Rating Scale (NRS) pain scale

Efficacy of Alocyte treatment as assessed by the change in Quality of Life (QoL) SF-12 questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Alocyte Medium doseExperimental Treatment1 Intervention

Subjects will receive medium dose injections in three facet joints

Group II: Alocyte Low doseExperimental Treatment1 Intervention

Subjects will receive low dose injection in a single facet joint

Group III: Alocyte High doseExperimental Treatment1 Intervention

Subjects will receive high dose injections in five facet joints

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for back pain often focus on reducing inflammation and promoting tissue repair. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen work by inhibiting enzymes that cause inflammation, providing pain relief. Biologic therapies, such as platelet-rich plasma (PRP) and stem cell treatments, aim to harness the body's natural healing processes. These therapies introduce growth factors and cells that can reduce inflammation and stimulate tissue regeneration. For back pain patients, these mechanisms are crucial as they not only alleviate pain but also address underlying tissue damage, potentially offering longer-term relief and improved function.