Intramuscular Injection of CELZ-201-DDT for Lower Back Pain

(ADAPT Trial)

Recruiting at 2 trial locations

Overseen By Creative Medical Technology

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Creative Medical Technology Holdings Inc

Must not be taking: Opioids, Immunosuppressants

Disqualifiers: Cancer, Spinal infections, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CELZ-201-DDT for individuals with chronic lower back pain. The goal is to determine the treatment's safety, tolerability, and effectiveness. Participants will receive injections of either CELZ-201-DDT (an experimental treatment) or a placebo (a substance with no active treatment) into their lower back muscles. Those who have experienced persistent lower back pain and have not found relief from physical therapy, pain medications, or muscle relaxants might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on opioid medications. If you are on chronic immunosuppressive therapy, you may not be eligible unless you are taking less than 5 mg of Prednisone daily.

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

Research shows that CELZ-201-DDT is being tested for safety and tolerability when administered as an intramuscular injection for lower back pain. Earlier reports found that this treatment significantly reduced pain, but they did not specify side effects. The FDA has granted CELZ-201-DDT fast-track status, indicating its promising safety profile, though final results are pending. Participants in the trial will be closely monitored for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for lower back pain, such as NSAIDs, opioids, or physical therapy, CELZ-201-DDT offers a novel approach by using stem cells delivered directly into the lumbar muscles. This treatment is distinctive because it potentially enhances the body’s natural healing processes through the direct administration of stem cells, which may help in repairing damaged tissue and reducing inflammation more effectively. Researchers are excited about CELZ-201-DDT because it combines a new delivery method with the promising regenerative capabilities of stem cells, offering hope for faster and more sustained pain relief.

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

Research has shown that CELZ-201-DDT, which participants in this trial may receive, may help treat chronic lower back pain. Early results indicate that this treatment can significantly reduce pain and improve movement. Initial data from earlier studies suggest it might ease back pain and help restore function. The treatment targets the muscles in the lower back, potentially providing relief when other methods have not worked. Thus, CELZ-201-DDT could be a good option for those dealing with chronic lower back pain. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Ability of participant to understand and the willingness to sign a written informed consent document

I agree to use birth control and not donate sperm during the study.

Exclusion Criteria

Your body mass index (BMI) is higher than 40.

My blood pressure is controlled under 140/90 mmHg with medication.

I do not have any active infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single administration of CELZ-201-DDT or placebo via six paraspinal intramuscular injections

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for long-term efficacy and safety, including changes in pain medication requirements

12 months

What Are the Treatments Tested in This Trial?

Interventions

• CELZ-201-DDT
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Medium Dose Experimental Treatment 2 Interventions

Subjects in the medium dose arm will receive a single administration of either 30x10\^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 Dose Experimental Treatment 2 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 Dose Experimental Treatment 2 Interventions

Subjects in the high dose arm will receive a single administration of either 60x10\^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.

CELZ-201-DDT is already approved in United States for the following indications:

Approved in United States as AlloStem for:

• Chronic Lower Back Pain

Who Is Running the Clinical Trial?

Creative Medical Technology Holdings Inc

Lead Sponsor

Trials

2

Recruited

50+

Published Research Related to This Trial

In a study of 305 patients with cervical dystonia, the most commonly injected muscles for botulinum neurotoxin type A (BoNT/A) were the splenius capitis and sternocleidomastoid, with average doses varying significantly between different types of BoNT/A.

The study found that the doses used in real-world clinical practice were lower than those in previous trials, potentially due to factors like the number of muscles treated per session and the use of ultrasound guidance for more accurate injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose per muscle in cervical dystonia: pooled data from seven movement disorder centres. Jost, WH., Drużdż, A., Pandey, S., et al.[2022]

The commentary discusses the effectiveness of intradiscal injection therapy for treating chronic low back pain associated with degenerative disc disease and Modic changes, highlighting its potential as a minimally invasive treatment option.

It emphasizes the need for further research to establish long-term safety and efficacy, as well as to better understand the mechanism of action behind this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modic changes and intradiscal steroids. O'Neill, C.[2011]

In a study involving 18 cervical dystonia patients, researchers successfully identified the motor endplate zones (MEZ) of relevant neck muscles using high-density surface electromyography, which is crucial for targeted treatment.

A follow-up study with 9 patients showed that half-dosed, endplate-targeted botulinum neurotoxin injections were as effective as standard full-dose injections, suggesting a potential for reduced medication use without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical utility of botulinum toxin injections targeted at the motor endplate zone in cervical dystonia. Delnooz, CC., Veugen, LC., Pasman, JW., et al.[2022]

Intradiscal injection therapy has been discussed as a potential treatment for chronic low back pain associated with degenerative disc disease and Modic changes, suggesting it may provide relief for patients suffering from this condition.

The commentary highlights the importance of understanding the underlying mechanisms of action and the safety profile of intradiscal injections to better assess their efficacy in managing chronic discogenic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Something is amiss. Fraser, RD.[2012]

Intradiscal platelet-rich plasma (PRP) injections for degenerative disc disease showed a statistically significant reduction in pain, with visual analog scale scores improving from 69.7 mm to 43.3 mm after treatment, based on a review of five studies involving 90 subjects.

The procedure had a low complication rate, with only 2.2% of patients experiencing lower extremity paresthesia and 1.1% requiring re-injection, indicating it may be a safe option for managing pain in degenerative disc disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic Review: Is an Intradiscal Injection of Platelet-Rich Plasma for Lumbar Disc Degeneration Effective? Hirase, T., Jack Ii, RA., Sochacki, KR., et al.[2020]

Using kinematic technology to guide botulinum toxin type A (BoNT-A) injections in cervical dystonia (CD) patients led to a significant 28.8% reduction in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score at week 6, indicating improved treatment outcomes compared to traditional visual assessment methods.

Both kinematic-guided ('kb') and visual assessment ('vb') groups showed similar reductions in TWSTRS scores, but the 'kb' group achieved these results more quickly and with potentially lower doses of BoNT-A, suggesting a more efficient and tailored approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized botulinum toxin type A therapy for cervical dystonia based on kinematic guidance. Samotus, O., Lee, J., Jog, M.[2018]

In a pilot study involving 35 patients receiving intradiscal restorative injections and 74 patients undergoing intradiscal electrothermal therapy (IDET), both treatments provided significant pain relief, with injections showing slightly better results (2.2 VAS) compared to IDET (1.27 VAS).

Patients receiving restorative injections reported a higher satisfaction rate (65.6%) compared to those undergoing IDET (47.8%), and while more patients experienced flare-ups after injections (81% vs. 68.9%), the duration of these flare-ups was shorter for injections (8.6 days) compared to IDET (33.1 days).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intradiscal restorative injections and intradiscal electrothermal treatment (IDET) in the treatment of low back pain. Derby, R., Eek, B., Lee, SH., et al.[2022]

Minimal-invasive injection therapy is an effective alternative for managing cervical spine syndromes, particularly for patients with ongoing spine pain who are not candidates for surgery.

The procedure requires specialized knowledge and expertise to ensure accurate placement of injections, which is crucial for overcoming pain and minimizing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Minimal-invasive injection therapy for cervical syndromes]. Grifka, J., Boluki, D., Linhardt, O., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07137559

CELZ-201-DDT for the Treatment of Chronic Lower Back ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo ...

2. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/celz-201-ddt-fda-clearance-for-chronic-lower-back-pain-trial/

Celz-201-DDT FDA Clearance for Chronic Lower Back ... The positive interim results, including statistically significant improvements in pain and mobility, suggest that CELZ-201-DDT could offer a ...

3. biospace.com biospace.com/press-releases/creative-medical-technology-holdings-announces-positive-initial-safety-tolerability-and-efficacy-data-from-first-cohort-in-phase-1-2-trial-of-celz-201-ddt-for-chronic-back-pain

Creative Medical Technology Holdings Announces ... Blinded preliminary data suggest encouraging therapeutic potential in alleviating back pain and restoring functionality. Following a ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06053242

Study Details | NCT06053242 | Safety, Tolerability, and ... Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain. The ...

5. businesswire.com businesswire.com/news/home/20230213005676/en/Three-Year-Follow-Up-Results-Confirm-Efficacy-of-StemSpine-Procedure-for-Treating-Chronic-Lower-Back-Pain-with-No-Serious-Adverse-Effects

Three Year Follow-Up Results Confirm Efficacy of ... The three-year data demonstrates continued efficacy of the StemSpine® procedure for treating chronic lower back pain without any serious adverse effects ...

6. rheumatologyadvisor.com rheumatologyadvisor.com/news/regenerative-stem-cell-based-therapy-fast-tracked-for-degenerative-disc-disease/

Regenerative Stem Cell-Based Therapy Fast Tracked for ... Findings from an interim analysis showed treatment with CELZ-201-DDT statistically significantly reduced pain (assessed by the visual analogue ...

7. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/celz-201-ddt-gets-fda-fast-track-for-chronic-lower-back-pain/

Celz-201-DDT Gets FDA Fast Track for Chronic Lower ... Looking ahead, the success of CELZ-201-DDT hinges on the final results of its ongoing clinical trial and subsequent regulatory review.

8. clinicaltrialsarena.com clinicaltrialsarena.com/news/creative-medical-trial-lower-back-pain/

Creative Medical to initiate trial of lower back pain treatment The FDA-approved, placebo-controlled, double-blind, randomised study is designed to assess the tolerability, efficacy and safety of CELZ-201-DDT.