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This is a Phase 2, randomized, double-blind, placebo-controlled, dose range finding study in subjects who have diabetic peripheral neuropathy (DPN). The study will enroll approximately 24 subjects. Subjects will be randomized to receive one of 3 treatments: PDA-002 (3 x 10^6 cells), PDA-002 (30 x 10^6 cells), or placebo (vehicle control) in a 1:1:1 randomization approach. Investigational product or placebo will be administered monthly (3 administrations total on Study Days 1, 29, and 57).
Subjects will undergo a Screening Period (up to 28 days in duration) to determine study eligibility and baseline levels of signs and symptoms of diabetic peripheral neuropathy (DPN) will be established. Subjects will then enter a Treatment Period (6 months in duration). During the Treatment Period, subjects will be evaluated on an ongoing basis (at 8 scheduled study visits). Subjects will receive intramuscular (IM) injections of investigational product (IP) on Study Days 1, 29, and 57 as fifteen 0.30 mL injections (below the knee and above the ankle) in one lower extremity in a blinded manner. After completing the Treatment Period, subjects will enter the Follow-up Period where they will continue to be evaluated at scheduled study visits over the subsequent months.
An analysis of all study data will occur after the last subject has completed Visit 9 (Month 6) and after the last scheduled study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDA-002 Dose Level 1: 3 x 10^6 cells | Experimental | 3 x 10^6 PDA-002 cells administered intramuscular (IM) on study Days 1, 29, and 57. |
|
| PDA-002 Dose Level 2: 30 x 10^6 cells | Experimental | 30 x 10^6 PDA-002 cells administered IM on study Days 1, 29, and 57. |
|
| Placebo | Placebo Comparator | Subjects will receive placebo administered IM on study days 1, 29, and 57. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDA-002 | Biological | PDA-002 cells administered intramuscular (IM) on study Days 1, 29, and 57. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in the epidermal nerve fiber density (ENFD) at 6 months, compared to baseline | Epidermal nerve fiber density is a measurement used to assess the extent of peripheral diabetic neuropathy. The number of nerve fibers in a skin biopsy will be counted and quantified. A reduction in the number of nerves fibers (EPND)is indicative of worsening neuropathy. | Baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Number of participants with adverse events | Up to approximately 2 years |
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Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study:
Males and females who are at least 18 years of age at the time of signing the informed consent document.
Subject must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements
Diabetes mellitus (DM) Type 2 as defined by the American Diabetes Association (ADA) or World Health Organization (WHO) criteria.
Meet established criteria for diabetic peripheral neuropathy (DPN) due to Type 2 diabetes with the following:
A female of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to treatment with study therapy. In addition, sexually active Females of Child Bearing Potential (FCBP) must agree to use 2 of the following adequate forms of contraception methods simultaneously such as: oral, inject able, or implantable hormonal contraception, tubal ligation, intrauterine device (IUD), barrier contraceptive with spermicide or vasectomized partner for the duration of the study.
Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with FCBP for the duration of the study
Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment:
26. History of hypersensitivity to any of the components of the product formulation (including bovine or porcine products, dextran 40, and dimethyl sulfoxide [DMSO]).
27. Subject has received an investigational agent -an agent or device not approved by the US Food and Drug Administration (FDA) for marketed use in any indication- within 90 days (or 5 half-lives, whichever is longer) prior to treatment with study therapy or planned participation in another therapeutic study prior to the completion of this study or has received previous gene or cell therapy at any time.
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| Name | Affiliation | Role |
|---|---|---|
| Sharmila Koppisetti | Celularity Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network, LLC- Southland Neurologic Associates - Los Alamitos | Garden Grove | California | 92845 | United States | ||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2022 | |
| Reset | Mar 3, 2022 | |
| Release | May 30, 2022 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2015 |
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|
| Placebo | Drug | Subjects will receive placebo administered on study days 1, 29, and 57. |
|
| SDS Clinial Trials, Inc |
| Orange |
| California |
| 92868 |
| United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Infinity Clinical Research, LLC | Sunrise | Florida | 33351 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Nerve And Muscle Center Of Texas | Houston | Texas | 77099 | United States |
| Endeavor Clinical Trials PA | San Antonio | Texas | 78229 | United States |
| Unrelease | Jun 10, 2022 |
| Release | Jul 25, 2022 |
| Reset | Aug 18, 2022 |
| Release | Feb 6, 2023 |
| Reset | Feb 28, 2023 |
| Release | May 7, 2026 |
| Reset | Jun 3, 2026 |
| Jan 31, 2022 |
| Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2022 | Mar 3, 2022 | |||
| May 30, 2022 | Jun 10, 2022 | |||
| Jul 25, 2022 | Aug 18, 2022 | |||
| Feb 6, 2023 | Feb 28, 2023 | |||
| May 7, 2026 | Jun 3, 2026 |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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