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Intramuscular Injection of CELZ-201-DDT for Lower Back Pain (ADAPT Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Creative Medical Technology Holdings Inc

Eligibility Criteria Checklist

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

Must have

Female subjects must not be breast feeding and must have no intention to become pregnant during the study, and she is using contraceptive drugs or devices

Proof for one of the following tests already performed in the clinical care of the patient for lower back pain: 1) MRI scan demonstrating at least one disc level with grade II or greater disc degeneration using the Pfirrmann grading system; 2) Oswestry Disability Index for Back Pain score of 21-80%; 3) Visual Analogue Scale for pain of >5 on a scale of 0-10

Must not have

Uncontrolled diabetes mellitus - HgA1c >8%

History of blood cell diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial will study a novel treatment for chronic lower back pain to see how safe, effective, and tolerable it is.

Who is the study for?

This trial is for adults aged 18-80 with chronic lower back pain who have not found relief from standard treatments. They must be willing to use contraception and cannot be pregnant, breastfeeding, or planning pregnancy. Participants should have a confirmed diagnosis of degenerative disc disease but can't join if they have severe kidney issues, liver problems, blood diseases, uncontrolled diabetes or hypertension, recent substance abuse history, obesity (BMI > 40), cancer within the last five years, infections including at the injection site or are on certain medications.

What is being tested?

The study tests CELZ-201-DDT's safety and effectiveness against placebo in managing chronic lower back pain through intramuscular injections near the spine. It aims to determine whether this treatment can provide relief when standard care has failed.

What are the potential side effects?

While specific side effects aren't listed here, common reactions to injections may include pain at the injection site, swelling, bruising and possible allergic reactions. The trial will assess CELZ-201-DDT's tolerability indicating close monitoring of any adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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I am not breastfeeding, do not plan to become pregnant, and am using birth control.

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I have had tests showing severe lower back issues or significant pain.

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I have tried exercise, painkillers, and muscle relaxants for 3 months each without relief.

Exclusion Criteria

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

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My diabetes is not under control, with an HgA1c over 8%.

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I have a history of blood cell diseases.

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I do not have any active infections.

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I do not have a severe illness that would limit my life to under 2 years.

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I have received gene therapy before.

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I am currently taking opioid medication.

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I need dialysis or my kidney function is low.

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I have had cancer within the last five years.

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I have a spinal infection or tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Evaluate safety of CELZ-201-DDT administered as intramuscular injections in subjects experiencing chronic lower back pain at a low, medium, or high dose.

Secondary study objectives

Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Medium DoseExperimental Treatment2 Interventions

Subjects in the medium dose arm will receive a single administration of either 12x10\^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.

Group II: Low DoseExperimental Treatment2 Interventions

Subjects in the low dose arm will receive a single administration of either 6x10\^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.

Group III: High DoseExperimental Treatment2 Interventions

Subjects in the high dose arm will receive a single administration of either 24x10\^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.

0 / 12Eligibility criteria met