Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers

NCT01859117 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CCT-PDA-002-DFU-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 12

Brief Summary

This Phase 1, multicenter, open-label, dose-escalation study evaluated the safety and tolerability of intramuscular administration of PDA-002 (human placenta-derived cells) in subjects with peripheral arterial disease (PAD) and diabetic foot ulcers (DFU).

Conditions

Diabetic Foot Ulcer; Peripheral Arterial Disease

Keywords

Peripheral arterial disease; diabetic foot ulcer; PAD; DFU

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLTs)

  Number of participants with dose-limiting toxicities following intramuscular administration of PDA-002. Dose-limiting toxicity was used to evaluate maximum tolerated dose.

  Through Day 15 following initial dosing

• Treatment-Emergent Adverse Events (TEAEs)

  Number of participants with treatment-emergent adverse events following administration of PDA-002.

  From first dose through month 24

Study Arms (4)

3 x10^6 cells

EXPERIMENTAL

Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 3 × 10\^6 cells.

Biological: PDA-002

10 x 10^6 cells

EXPERIMENTAL

Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 10 × 10\^6 cells.

Biological: PDA-002

30 x 10^6 cells

EXPERIMENTAL

Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 30 × 10\^6 cells.

Biological: PDA-002

100 x 10^6 cells

EXPERIMENTAL

Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 100 × 10\^6 cells.

Biological: PDA-002

Interventions

PDA-002 BIOLOGICAL

Human placenta-derived cells administered intramuscularly on Study Days 1 and 8.

10 x 10^6 cells; 100 x 10^6 cells; 3 x10^6 cells; 30 x 10^6 cells

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Males and females, 18 to 80 years of age 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 2
• Ischemic or neuro-ischemic 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.
• Peripheral arterial disease with ankle-brachial index \> 0.5 and ≤ 0.9 or toe-brachial index \> 0.35 and ≤ 0.7.
• 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 2 weeks after a failed reperfusion intervention and at least 2 months after a successful mechanical intervention.
• Subject can have stable angina, (Canadian Cardiovascular Society (CCS) Class I-II angina (Appendix H).
• Subjects should be receiving appropriate medical therapy for hypertension and diabetes.
• A female of childbearing potential \[FCBP\] 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; intrauterine device \[IUD\]; 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:

• The presence of any of the following will exclude a subject from enrollment:
• 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.
• Subjects whom, in the judgment of the Investigator, are at elevated risk for the development of a malignancy. This judgment may be based on family history, history of industrial exposures, smoking history or other cancer risk factors.
• Known to be positive for human immunodeficiency virus.
• Pregnant or lactating females.
• Subjects with a body mass index \> 40 at Screening.
• Aspartate transaminase (AST) or Alanine transaminase (ALT) \> 2.5 x the upper limit of normal (ULN) at Screening.
• Estimated Glomerular Filtration Rate (eGFR) \< 45 mL/min/1.73 m2 at Screening calculated using the Modification of Diet in Renal Disease Study equation (Levey, 2006) or history of eGFR decline \> 15 mL/min/1.73 m2 in the past year.
• Alkaline phosphatase \> 2.5 x the ULN at Screening.
• 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, within 4 weeks prior to dosing with investigational product \[IP\].
• Known osteomyelitis.
• Ulcer that has decreased or increased in size by ≥ 50% during the screening period.

Sponsors & Collaborators

• Celularity Incorporated: lead

Study Sites (12)

Carl T. Hayden Veterans Affairs Medical Center

Phoenix, Arizona, 85012, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

VA Palo Alto health

Palo Alto, California, 94304, United States

Location

Dr. Wiliam M. Scholl College of Podiatric Medicine

North Chicago, Illinois, 60064, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Vascular Surgeon

Minneapolis, Minnesota, 55407, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Complete Family Foot Care - McAllen Office

McAllen, Texas, 78501-2930, United States

Location

Endeavor Clinical Trials PA

San Antonio, Texas, 78229, United States

Location

University of Virginia

Charlottesville, Virginia, 22908-0709, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Wu SC, Pollak R, Frykberg RG, Zhou W, Karnoub M, Jankovic V, Fischkoff SA, Chitkara D. Safety and efficacy of intramuscular human placenta-derived mesenchymal stromal-like cells (cenplacel [PDA-002]) in patients who have a diabetic foot ulcer with peripheral arterial disease. Int Wound J. 2017 Oct;14(5):823-829. doi: 10.1111/iwj.12715. Epub 2017 Jan 30.

  PMID: 28133924 RESULT

• Francki A, Labazzo K, He S, Baum EZ, Abbot SE, Herzberg U, Hofgartner W, Hariri R; Celgene Cellular Therapeutics Research Group. Angiogenic properties of human placenta-derived adherent cells and efficacy in hindlimb ischemia. J Vasc Surg. 2016 Sep;64(3):746-756.e1. doi: 10.1016/j.jvs.2015.04.387. Epub 2015 Jun 6.

  PMID: 26054585 DERIVED

Related Links

• publication

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

Limitations and Caveats

This was a Phase 1 open-label dose-escalation study without a control group. The study was designed primarily to evaluate safety and tolerability, and was not powered for formal efficacy comparisons.

Results Point of Contact

• Title: Dr. Sharmila Koppisetti
• Organization: Celularity

sharmila.koppisetti@celularity.com

973-768-2170

Study Officials

• sharmila koppisetti, MD

  Celularity Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 21, 2013
• Study Start: May 23, 2013
• Primary Completion: October 1, 2016
• Study Completion: March 14, 2017
• Last Updated: June 4, 2026
• Results First Posted: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)