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

Trial Summary

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.

What data supports the effectiveness of the treatment CELZ-201-DDT for lower back pain?

Research on similar treatments, like intradiscal injections with platelet-rich plasma (PRP) and other restorative injections, shows significant pain relief in patients with chronic low back pain. These studies suggest that injection therapies can be effective in reducing pain and improving patient satisfaction. ^{1 2 3 4 5}

How is the CELZ-201-DDT treatment for lower back pain different from other treatments?

CELZ-201-DDT is unique because it involves an intramuscular injection (injection into the muscle) of a stem cell-based therapy, which is different from traditional treatments like oral medications or physical therapy. This approach may offer a novel way to address lower back pain by potentially regenerating damaged tissues, unlike standard treatments that primarily focus on pain relief. ^{1 2 6 7 8}

What is the purpose of this trial?

The brief purpose of this research study is to learn about the safety, tolerability, and efficacy of paraspinal intramuscular injection of CELZ-201-DDT in patients with chronic lower back pain.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Something is amiss. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Modic changes and intradiscal steroids. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Systemic Review: Is an Intradiscal Injection of Platelet-Rich Plasma for Lumbar Disc Degeneration Effective? [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of intradiscal restorative injections and intradiscal electrothermal treatment (IDET) in the treatment of low back pain. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Minimal-invasive injection therapy for cervical syndromes]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

The clinical utility of botulinum toxin injections targeted at the motor endplate zone in cervical dystonia. [2022]

7. Poland pubmed.ncbi.nlm.nih.gov

Dose per muscle in cervical dystonia: pooled data from seven movement disorder centres. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Personalized botulinum toxin type A therapy for cervical dystonia based on kinematic guidance. [2018]