Chronic Back PainADAPTNCT07137559
CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
A study testing CELZ-201-DDT in people with Chronic Back Pain and Degenerative Disc Disease Lumbar, run by Creative Medical Technology Holdings Inc.
Trial summary
CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Back Pain, Degenerative Disc Disease Lumbar
- What is being tested?
- CELZ-201-DDT
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of chronic lower back pain due to degenerative disc disease.
- No comparable or satisfactory alternative therapy available. Unable to participate in the ongoing CELZ-201-DDT clinical trial. Informed consent provided.
Who cannot join
- Any medical condition that poses an unacceptable risk or would interfere with treatment safety or evaluation.
- Known hypersensitivity to any component of the investigational product.
- How to Request Access:
- Contact the Expanded Access Coordinator to confirm eligibility and discuss feasibility.
- Complete and submit FDA Form 3926 to the appropriate FDA review division.
- Obtain IRB review (may be expedited or post-treatment for emergency use). Coordinate drug shipment and treatment schedule.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expanded Access Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.
Read the detailed description
Expanded Access to CELZ-201-DDT (Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells) is available for individual patients with serious or life-threatening chronic lower back pain due to degenerative disc disease (DDD) who have no comparable or satisfactory alternative therapy options.
Requests will be considered on a case-by-case basis under a single-patient IND in coordination with the U.S. Food and Drug Administration (FDA) and an Institutional Review Board (IRB).
For non-emergency requests, the treating physician must submit FDA Form 3926 and obtain FDA authorization before initiating treatment.
For emergency use, treatment may begin without prior FDA authorization if criteria for emergency use are met; the physician must notify the FDA within 5 working days after treatment.
- Being tested
- CELZ-201-DDT
- Keywords
- CELZ-201-DDT, Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells, Mesenchymal Stromal Cells (MSC), Chronic Lower Back Pain, Degenerative Disc Disease (DDD), Lumbar Degeneration, Chronic Pain, Expanded Access, Single Patient IND, Emergency Use IND, Non-Emergency Use IND, Compassionate Use, Regenerative Medicine, Stem Cell Therapy
- Medical subject headings
- Intervertebral Disc Degeneration, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELZ-201-DDTDrug
CELZ-201-DDT is administered via intramuscular injection.
Dosing, administration, and follow-up will be determined by the treating physician in accordance with the EA authorization and medical judgment. Safety monitoring will be performed during and after treatment, and all serious adverse events will be reported to the FDA and IRB per applicable regulations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Creative Medical Technology Holdings Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137559
- Sponsor's protocol ID
- ADAPT Expanded Access
- Other IDs
- NCT 06053242
- Acronym
- ADAPT
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
- ClinicalTrials.gov ID
- NCT07137559
- Acronym / sponsor ID
- ADAPT / ADAPT Expanded Access
- Keywords
- CELZ-201-DDT, Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells, Mesenchymal Stromal Cells (MSC), Chronic Lower Back Pain, Degenerative Disc Disease (DDD), Lumbar Degeneration, Chronic Pain, Expanded Access
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Creative Medical Technology Holdings IncIndustry (pharma, biotech, devices)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.
Detailed description
Expanded Access to CELZ-201-DDT (Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells) is available for individual patients with serious or life-threatening chronic lower back pain due to degenerative disc disease (DDD) who have no comparable or satisfactory alternative therapy options.
Requests will be considered on a case-by-case basis under a single-patient IND in coordination with the U.S. Food and Drug Administration (FDA) and an Institutional Review Board (IRB).
For non-emergency requests, the treating physician must submit FDA Form 3926 and obtain FDA authorization before initiating treatment.
For emergency use, treatment may begin without prior FDA authorization if criteria for emergency use are met; the physician must notify the FDA within 5 working days after treatment.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of chronic lower back pain due to degenerative disc disease.
- No comparable or satisfactory alternative therapy available. Unable to participate in the ongoing CELZ-201-DDT clinical trial. Informed consent provided.
Key exclusion criteria (6 listed)
- Any medical condition that poses an unacceptable risk or would interfere with treatment safety or evaluation.
- Known hypersensitivity to any component of the investigational product.
- Contact the Expanded Access Coordinator to confirm eligibility and discuss feasibility.
- Complete and submit FDA Form 3926 to the appropriate FDA review division.
- Obtain IRB review (may be expedited or post-treatment for emergency use). Coordinate drug shipment and treatment schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CELZ-201-DDTCELZ-201-DDT is administered via intramuscular injection. Dosing, administration, and follow-up will be determined by the treating physician in accordance with the EA authorization and medical judgment. Safety monitoring will be performed during and after treatment, and all serious adverse events will be reported to the FDA and IRB per applicable regulations. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing CELZ-201-DDT in people with Chronic Back Pain and Degenerative Disc Disease Lumbar, run by Creative Medical Technology Holdings Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Creative Medical Technology ((702) 588-1890, expandedaccess@creativemedicaltechnology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.