A Efficacy and Safety Study of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Diabetic Peripheral Neuropathy

NCT02552277 | Completed Phase 2 DMC

• 1 other identifier: CCT-PDA-002-DPN-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

Brief Summary

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).

Conditions

Diabetic Nephropathies; Peripheral Nervous System Diseases

Keywords

Diabetic; PDA-002; Placenta-Derived Cells; Peripheral neuropathy; Neuropathy; Double-Blind; Safety; Efficacy; Human Placenta-derived Cells

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Adverse Events (AEs)

  Up to approximately 2 years

Study Arms (3)

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.

Biological: PDA-002

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.

Biological: PDA-002

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo administered IM on study days 1, 29, and 57.

Drug: Placebo

Interventions

PDA-002 BIOLOGICAL

PDA-002 cells administered intramuscular (IM) on study Days 1, 29, and 57.

Also known as: HUMAN PLACENTA-DERIVED CELLS

PDA-002 Dose Level 1: 3 x 10^6 cells; PDA-002 Dose Level 2: 30 x 10^6 cells

Placebo DRUG

Subjects will receive placebo administered on study days 1, 29, and 57.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Abnormal symptoms 6-item Neuropathy Total Symptom Score (NTSS-6 ≥ 6 points (total score) or ≥ 2.0 points for one or more symptoms) AND
• Abnormal signs; Utah Early Neuropathy Scale (UENS) score of 2-24 and/or Neurological Impairment Score of the Lower Limb (NIS-LL) score of 2-10.
• 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

You may not qualify if:

• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Other causes of neuropathy in diabetic subjects: chronic inflammatory demyelinating polyneuropathy; neuropathy due to vitamin B12 deficiency, hypothyroidism, and uremia syndrome; and neuropathy due to entrapment or trauma.
• A reversible course of acute painful diabetic neuropathy syndrome: treatment-induced diabetic neuropathy that presents in the setting of rapid glycemic control; diabetic neuropathic cachexia; and diabetic anorexia, a diabetic neuropathy that is seen with intentional weight loss.
• History of a prior diagnosis of severe peripheral arterial disease (PAD).
• Thrombocytopenia and coagulopathy, to avoid severe bruising or bleeding due to multiple intramuscular (IM) injections.
• Any condition including the presence of laboratory abnormalities that places the subject at unacceptable risk if he or she were to participate in the study.
• Any condition that confounds the ability to interpret data from the study.
• Subjects who are taking opioids for the treatment of DPN.
• Pregnant or lactating females.
• Subjects with a body mass index \> 40 kilgrams (kg)/m\^2 at screening.
• Neuropathy resulting from a condition other than DM and/or significant co-morbid neurological diseases (eg, Parkinson's disease, epilepsy, multiple sclerosis, alcoholic peripheral neuropathy), or exposure to agents suspected to cause symptoms of neuropathy (such as but not limited to metronidazole, antituberculosis medications, and heavy metals).
• Advanced neuropathy as measured by the absence of sural sensory nerve action potential, or a UENS\>24 and or a NIS-LL\>10.
• History of a prior diagnosis of Critical Limb Ischemia.
• History of diabetic foot ulceration (at any time) and/or or undergoing a limb revascularization procedure(s) and/or amputation(s) due to diabetes mellitus (DM).
• Diagnosis of Type 1 DM and/or any of the following: diagnosis of DM prior to age 35 years; insulin required to treat DM within 1 year after DM diagnosis; history of diabetic ketoacidosis.

Sponsors & Collaborators

• Celularity Incorporated: lead

Study Sites (7)

Collaborative Neuroscience Network, LLC- Southland Neurologic Associates - Los Alamitos

Garden Grove, California, 92845, United States

Location

SDS Clinial Trials, Inc

Orange, California, 92868, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Infinity Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Nerve And Muscle Center Of Texas

Houston, Texas, 77099, United States

Location

Endeavor Clinical Trials PA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Sharmila Koppisetti

  Celularity Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 17, 2015
• Study Start: October 27, 2015
• Primary Completion: March 7, 2017
• Study Completion: October 30, 2017
• Last Updated: February 2, 2022

Record last verified: 2022-02

Locations

US (7)