Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.

NCT02264288 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CCT-PDA-002-DFU-002
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 45

Brief Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with diabetic foot ulcers (DFU), including subjects with and without peripheral arterial disease (PAD). Subjects were randomized to receive one of three dose levels of PDA-002 or placebo. Randomization was stratified by PAD status. The study evaluated wound healing and safety outcomes over the follow-up period.

Conditions

Diabetic Foot; Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Diabetic Foot; Placenta Derived Stem Cells

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months

  Complete wound closure is defined as closure of the index ulcer within 3 months after dosing and retaining wound closure for the subsequent 4 weeks.

  Within 3 months after dosing, with confirmation over the subsequent 4 weeks

Secondary Outcomes (2)

• Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months by PAD Status

  Within 3 months after dosing, with confirmation over the subsequent 4 weeks

• Percentage of Subjects With Improvement in Rutherford Classification at Month 3 in Subjects With PAD

  Month 3

Other Outcomes (4)

• Change From Baseline in Toe-Brachial Index (TBI) at Month 6

  Baseline and Month 6

• Change From Baseline in Transcutaneous Oxygen Pressure (TcPO2) at Month 6

  Baseline and Month 6

• Change From Baseline in Ankle-Brachial Index (ABI) at Month 6

  Baseline and Month 6

Study Arms (4)

PDA-002 3 x 10^6 cells

EXPERIMENTAL

Subjects randomized to receive PDA-002 at a dose of 3 × 10\^6 cells administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD).

Biological: PDA-002

PDA-002 10 x 10^6 cells

EXPERIMENTAL

Subjects randomized to receive PDA-002 at a dose of 10 × 10\^6 cells administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD).

Biological: PDA-002

PDA-002 30 x 10^6 cells

EXPERIMENTAL

Subjects randomized to receive PDA-002 at a dose of 30 × 10\^6 cells administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD).

Biological: PDA-002

Placebo

PLACEBO COMPARATOR

Subjects randomized to receive matching placebo administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status.

Other: Placebo

Interventions

Placebo OTHER

Matching placebo administered intramuscularly on Study Days 1 and 8.

Placebo

PDA-002 BIOLOGICAL

Human placenta-derived cells administered intramuscularly on Study Days 1 and 8 at assigned dose levels.

PDA-002 10 x 10^6 cells; PDA-002 3 x 10^6 cells; PDA-002 30 x 10^6 cells

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, at least 18 years of age or older at the time of signing the informed consent document.
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
• Able to adhere to the study visit schedule and other protocol requirements.
• Diabetes mellitus Type 1 or Type 2.
• Diabetic foot ulcer with severity of Grade 1 (full thickness only) or Grade 2 on the Wagner Grading Scale (Appendix A) of greater than one month duration which has not adequately responded to conventional ulcer therapy with a size of at least of 1cm2 except if present on the toe. The maximum lesion size range in the index ulcer is ≤ 10cm2. The measurement of the index ulcer is to be evaluated and measured after debridement (if necessary) at the Screening Visit. If located on the plantar aspect of the foot, the index ulcer must be able to be adequately offloaded in the assessment of the investigator.
• No planned revascularization or amputation over the next 3 months after Screening visit, in the opinion of the Investigator.
• Screening should not begin until at least 14 days after a failed reperfusion intervention and at least 30 days after a successful reperfusion intervention.
• Subjects should be receiving appropriate medical therapy for hypertension and diabetes any other chronic medical conditions for which they require ongoing care.
• 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 FCBP must agree to use 2 of the following adequate forms of contraception methods simultaneously such as: oral, injectable, or implantable hormonal contraception; tubal ligation; IUD; barrier contraceptive with spermicide or vasectomized partner for the duration of the study and the Follow-up Period.
• Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP for the duration of the study and the Follow-up Period.

You may not qualify if:

• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Any condition including the presence of laboratory abnormalities, which 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.
• Pregnant or lactating females.
• Subjects with a body mass index \> 45 kg/m2 at Screening.
• AST (SGOT) or ALT (SGPT) \> 2.5 x the upper limit of normal (ULN) at Screening.
• Patient on renal dialysis for abnormal kidney function.
• An ABI \< 0.4 and or TBI \< 0.3 in the leg with the index ulcer.
• Bilirubin level \> 2 mg/dL (unless subject has known Gilbert's disease) at Screening.
• Untreated chronic infection or treatment of any infection with systemic antibiotics, including the ulcer site, must be free of antibiotics within 1 week prior to dosing with IP.
• Active osteomyelitis, infection, or cellulites at or adjacent to the index ulcer. Patients with a history of being treated for an osteomyelitis without a surgical resection.
• Index ulcer that has decreased or increased in size by ≥ 30% during the Screening/Run-In/ Pre-Treatment Period.
• Active Charcot Neuroarthropathy in the foot with the index ulcer
• Pain at rest due to limb ischemia.
• Uncontrolled hypertension (defined as diastolic blood pressure \> 100 mmHg or systolic blood pressure \> 180 mmHg during Screening at 2 independent measurements taken while subject is sitting and resting for at least 5 minutes).

Sponsors & Collaborators

• Celularity Incorporated: lead

Study Sites (45)

Cardiology PC

Birmingham, Alabama, 35211, United States

Location

Swagel wootoon hiatt eye center

Mesa, Arizona, 85206, United States

Location

Carl T. Hayden Veterans Affairs Medical Center

Phoenix, Arizona, 85012, United States

Location

Arizona Arthritis and Rheumatology Research, PLLC

Phoenix, Arizona, 85023, United States

Location

NEA baptist clinic

Jonesboro, Arkansas, 72401, United States

Location

Jeffrey A Klemes DPM

Beverly Hills, California, 90211, United States

Location

Reliance Clinical Research

Chino, California, 91710, United States

Location

Limb Preservation Platform, INC.

Fresno, California, 93720, United States

Location

Foot and Ankle Clinic

Los Angeles, California, 90057, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Center for Clinical Research Inc.

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94063, United States

Location

Animas Foot and Ankle

Durango, Colorado, 81301, United States

Location

Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia, 20007-2197, United States

Location

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida, 33765, United States

Location

Florida Research Network, LLC

Gainesville, Florida, 32605, United States

Location

The Research Center

Hialeah, Florida, 33012, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

Solutions Through Advanced Research Inc.

Jacksonville, Florida, 32258, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Well Pharma Medical Research Corporation

Miami, Florida, 33143, United States

Location

GF Professional Research Group Corporation

Miami Lakes, Florida, 33016, United States

Location

Podiatry 1st

Belleville, Illinois, 62226, United States

Location

Weill Foot & Ankle Institute

Des Plaines, Illinois, 60016, United States

Location

Rosalind Franklin University of Medicine and Science

North Chicago, Illinois, 60064, United States

Location

Foot and Ankle Center of Illinois

Springfield, Illinois, 62704, United States

Location

CGH Medical Center Main Clinic

Sterling, Illinois, 61081, United States

Location

Hamilton Foot Care

Baltimore, Maryland, 21214, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Northwest Hospital

Randallstown, Maryland, 21133, United States

Location

Revive Research Institute

Sterling Heights, Michigan, 48313, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Office of Michael J. De Marco, DPM

Newark, New Jersey, 07102, United States

Location

Ocean City Foot and Ankle Assoc

Toms River, New Jersey, 08753, United States

Location

UNC Hospitals University of North Carolina

Chapel Hill, North Carolina, 27599-7010, United States

Location

Bert J Altmanshofer and associates, LTD

Duncansville, Pennsylvania, 16635, United States

Location

University of Pennsylvania Health Systems

Philadelphia, Pennsylvania, 19104, United States

Location

Premier Vein and Vascular Center

Houston, Texas, 77084, United States

Location

Futuro Clinical trials

McAllen, Texas, 78501-2930, United States

Location

Endeavor Clinical Trials PA

San Antonio, Texas, 78229, United States

Location

SAM Clinical Research Center

San Antonio, Texas, 78229, United States

Location

Advanced Foot & Ankle Center

Salt Lake City, Utah, 84102, United States

Location

Carilion Clinic

Roanoke, Virginia, 24013, United States

Location

1Foot 2Foot Centre for Foot & Ankle Care PC

Suffolk, Virginia, 23434, United States

Location

Milwaukee Foot & Ankle Specialists

Wauwatosa, Wisconsin, 53226, United States

Location

Related Publications (1)

• Pollak R, Anderson J, Altmanshofer B, Caporusso J, Fantini G, Koppisetti S, Brigido S, Hariri R. Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomised, Double-Blind, Placebo-Controlled Trial. Int Wound J. 2025 Oct;22(10):e70769. doi: 10.1111/iwj.70769.

  PMID: 41077558 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetic Foot

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Sharmila Koppisetti
• Organization: Celularity, Inc

sharmila.koppisetti@celularity.com

9088454231

Study Officials

• Sharmila Koppisetti, MD

  Celularity Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 15, 2014
• Study Start: October 23, 2014
• Primary Completion: February 27, 2018
• Study Completion: February 27, 2018
• Last Updated: June 12, 2026
• Results First Posted: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (45)