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

Phase 1 & 2
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

ADAPT Trial 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.Check my eligibility
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.See study design
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.

ADAPT Trial 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.

ADAPT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.

ADAPT 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.

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Who is running the clinical trial?

Creative Medical Technology Holdings IncLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
~20 spots leftby May 2025
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