NCT01859117

Brief Summary

This clinical study is being conducted to assess the safety and determine the maximum tolerated dose (MTD) of PDA-002 \[human placenta-derived cells\] administered into the lower leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer healing. This study will also help to find the best dose of PDA-002 to use in future studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2013

Typical duration for phase_1

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2017

Enrollment Period

3.4 years

First QC Date

May 17, 2013

Last Update Submit

February 27, 2018

Conditions

Peripheral Arterial DiseaseDiabetic Foot

Keywords

Peripheral arterial diseasediabetic foot

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose

    To determine the maximum tolerated dose (MTD) of PDA-002 administered intramuscularly (IM) in subjects with peripheral arterial disease (PAD) and DFU \[diabetic foot ulcer\].

    14 days of initial dosing

  • Adverse Events

    Number of participants with adverse events

    From signing informed consent until month 24

Secondary Outcomes (2)

  • Ankle-brachial index (ABI)

    Approximately 2 years

  • Toe-brachial index (TBI)

    Approximately 2 years

Study Arms (4)

3 x 10^6 cells

EXPERIMENTAL

3 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8

Biological: 3 x 10^6 cells

10 x 10^6 cells

EXPERIMENTAL

10 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8

Biological: 10 x 10^6 cells

30 x 10^6 cells

EXPERIMENTAL

30 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8

Biological: 30 x 10^6 cells

100 x 10^6 cells

EXPERIMENTAL

100 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8

Biological: 100 x 10^6 cells

Interventions

3 x 10^6 cellsBIOLOGICAL

3 x 10\^6 cells administered on Study Days 1 and 8

Also known as: PDA-002
3 x 10^6 cells
10 x 10^6 cellsBIOLOGICAL

10 x 10\^6 cells administered on Study Days 1 and 8

Also known as: PDA-002
10 x 10^6 cells
30 x 10^6 cellsBIOLOGICAL

30 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8

Also known as: PDA-002
30 x 10^6 cells
100 x 10^6 cellsBIOLOGICAL

100 x 10\^6 cells administered on Study Days 1 and 8

Also known as: PDA-002
100 x 10^6 cells

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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 \> 0.6 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.
  • Not a candidate for peripheral artery percutaneous or surgical revascularization.
  • 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.
  • Subject must be a non-tobacco user defined as someone who has not used tobacco/nicotine patch for ≥ 3 months and must agree to remain tobacco/nicotine free for the duration of the study.
  • 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 \> 35 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.
  • History of Methicillin-resistant Staphylococcus aureus (MRSA).
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Carl T. Hayden Veterans Affairs Medical Center

Phoenix, Arizona, 85012, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Stanford University School of Medicine

Stanford, California, 94305-5317, 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

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 (1)

  • 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: 26054585DERIVED

MeSH Terms

Conditions

Peripheral Arterial DiseaseDiabetic Foot

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesDiabetic AngiopathiesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Monica E Luchi, MD

    Celularity Incorporated

    STUDY DIRECTOR

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 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 1, 2018

Record last verified: 2017-02

Locations

US(11)