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Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain (ADAPT)

Primary Purpose

Chronic Low-back Pain, Degenerative Disc Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CELZ-201-DDT
Placebo
Sponsored by
Creative Medical Technology Holdings Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ability of participant to understand and the willingness to sign a written informed consent document. Between 18-80 years of age and may be of either gender or any race. Subjects must have failed at least two standard of care (SOC) therapies before being enrolled in the study: 1) exercise/physical therapy; 2) oral analgesic including nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen; 3) skeletal muscle relaxants. Subjects must have tried each SOC therapy for at least 3 months before failure is determined. Patients must have failed the SOC therapies within 12 months of enrollment in the clinical trial. 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. 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. Any male subject must agree to use contraceptives and not donate sperm during the study. Exclusion Criteria: History of cancer in the last five years. Spinal infections and spinal tumors. Renal insufficiency requiring dialysis or an eGFR of less than 60 mL/min/1.73m2. ALT, AST greater than 2 times or Total Bilirubin 1.5 times the upper limit of the normal range. Positive pregnancy test. History of blood cell diseases. Uncontrolled diabetes mellitus - HgA1c >8%. Uncontrolled hypertension defined as a systolic blood pressure of >140 mmHg or diastolic blood pressure of >90 mmHg at the time of screening. If subjects have their hypertension appropriately treated, then they would be eligible to enroll. Patients known to have any active infection, including infection of the injection site(s), and/or any active systemic or local infection. Patients on chronic immunosuppressive transplant therapy. Patients receiving <5 mg of Prednisone daily may be included. Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years. Recent smoking history or substance abuse (within six weeks). Heavy alcohol use (greater than 14 drinks per week for men or 7 drinks per week for women per NIAAA) Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving study treatment. Any patient who has received gene therapy in the past. Subjects who are currently on opioid medication(s). Body Mass Index (BMI) > 40 kg/m2.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low Dose

Medium Dose

High Dose

Arm Description

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.

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.

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.

Outcomes

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.
The primary outcome will be evaluated by the incidence of grade 3 or 4 or serious adverse events in all dosing cohorts at 6 months.

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.
The secondary outcome will be evaluated by change in pain as judged by the Visual Analogue Score (VAS), using a score of 0-10.
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 secondary outcome will be evaluated by change in disability as judged by the Oswestry Disability Index (ODI) for back pain.
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 secondary outcome will be evaluated by change in requirements for pain medications to manage back pain.

Full Information

First Posted
September 17, 2023
Last Updated
September 25, 2023
Sponsor
Creative Medical Technology Holdings Inc
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1. Study Identification

Unique Protocol Identification Number
NCT06053242
Brief Title
Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
Acronym
ADAPT
Official Title
A Double-blinded, Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Effectiveness of CELZ-201-DDT Administered by Intramuscular Injection for the Treatment of Chronic Lower Back Pain in Patients With Degenerative Disc Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creative Medical Technology Holdings Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
This study is a double-blinded, randomized, placebo-controlled, dose escalation Phase 1/2a study. The objective is to determine the safety, tolerability, and efficacy of CELZ-201-DDT administered as an intramuscular injection for the treatment of lower back pain in patients with Degenerative Disc Disease. Subjects who meet all criteria for inclusion will be enrolled and randomized into either low, medium or high dose of CELZ-201-DDT versus Placebo, with a total of 30 subjects enrolled. Each dosing cohort will contain ten subjects (n=10), with eight subjects (n=8) receiving the investigational product and two subjects (n=2) randomized to receive placebo. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Degenerative Disc Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Medium Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
High Dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CELZ-201-DDT
Intervention Description
Subjects enrolled in the trial will receive CELZ-201-DDT at the specified dose into the lumbar paraspinal musculature. Each subject will receive a total of six injections, three injections on each side, under direct ultrasound guidance.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive a placbeo injection into the lumbar paraspinal musculature. Each subject will receive a total of six injections, three injections on each side, under direct ultrasound guidance.
Primary Outcome Measure Information:
Title
Evaluate safety of CELZ-201-DDT administered as intramuscular injections in subjects experiencing chronic lower back pain at a low, medium, or high dose.
Description
The primary outcome will be evaluated by the incidence of grade 3 or 4 or serious adverse events in all dosing cohorts at 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.
Description
The secondary outcome will be evaluated by change in pain as judged by the Visual Analogue Score (VAS), using a score of 0-10.
Time Frame
12 months
Title
Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.
Description
The secondary outcome will be evaluated by change in disability as judged by the Oswestry Disability Index (ODI) for back pain.
Time Frame
12 months
Title
Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.
Description
The secondary outcome will be evaluated by change in requirements for pain medications to manage back pain.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability of participant to understand and the willingness to sign a written informed consent document. Between 18-80 years of age and may be of either gender or any race. Subjects must have failed at least two standard of care (SOC) therapies before being enrolled in the study: 1) exercise/physical therapy; 2) oral analgesic including nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen; 3) skeletal muscle relaxants. Subjects must have tried each SOC therapy for at least 3 months before failure is determined. Patients must have failed the SOC therapies within 12 months of enrollment in the clinical trial. 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. 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. Any male subject must agree to use contraceptives and not donate sperm during the study. Exclusion Criteria: History of cancer in the last five years. Spinal infections and spinal tumors. Renal insufficiency requiring dialysis or an eGFR of less than 60 mL/min/1.73m2. ALT, AST greater than 2 times or Total Bilirubin 1.5 times the upper limit of the normal range. Positive pregnancy test. History of blood cell diseases. Uncontrolled diabetes mellitus - HgA1c >8%. Uncontrolled hypertension defined as a systolic blood pressure of >140 mmHg or diastolic blood pressure of >90 mmHg at the time of screening. If subjects have their hypertension appropriately treated, then they would be eligible to enroll. Patients known to have any active infection, including infection of the injection site(s), and/or any active systemic or local infection. Patients on chronic immunosuppressive transplant therapy. Patients receiving <5 mg of Prednisone daily may be included. Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years. Recent smoking history or substance abuse (within six weeks). Heavy alcohol use (greater than 14 drinks per week for men or 7 drinks per week for women per NIAAA) Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving study treatment. Any patient who has received gene therapy in the past. Subjects who are currently on opioid medication(s). Body Mass Index (BMI) > 40 kg/m2.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Creative Medical Technology
Phone
(702) 588-1890
Email
clinicaltrials@creativemedicaltechnology.com
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Creative Medical
Phone
702-588-1890

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain

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