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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 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

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Creative Medical Technology Holdings IncLead Sponsor

1 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which patient population is best suited for this medical research project?

"In order to be selected for this medical study, candidates should have a diagnosis of degenerative disc disease and fall within the acceptable age range (18-80). The trial is looking to recruit approximately 30 individuals."

Answered by AI

Does the research involve adults aged 25 and above?

"This medical trial seeks participants aged 18 to 80 years old. In addition, there are 9 studies specifically targeting those younger than 18 and 306 other trials that focus on individuals over 65."

Answered by AI

Are there any openings remaining for this investigation?

"Clinicaltrials.gov confirms that this medical study, which was initially posted on November 1st 2023 and updated most recently on September 21st 2023, is no longer actively enrolling participants. However, there are currently 380 other clinical trials seeking patients now."

Answered by AI