Peripheral Arterial DiseasePhase 1NCT01859117
Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
A Phase 1 study testing PDA-002 in people with Peripheral Arterial Disease and Diabetic Foot Ulcer, run by Celularity Incorporated at 12 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease, Diabetic Foot Ulcer
- What is being tested?
- PDA-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 12 sitesUnited States
- Study dates
- 23 May 2013to 14 Mar 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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).
- Poorly controlled diabetes mellitus (hemoglobin A1c > 9%).
- Untreated proliferative retinopathy.
- History of malignant ventricular arrhythmia, CCS Class III-IV angina pectoris, myocardial infarction/PCI (percutaneous coronary intervention)/CABG (coronary artery bypass graft) in the preceding 6 months, pending coronary revascularization in the following 2 months, transient ischemic attack/cerebrovascular accident in the preceding 6 months, and/or New York Heart Association [NYHA] Stage III or IV congestive heart failure, (Appendix C).
- Abnormal ECG: new bundle branch block (BBB) ≥ 120 msec in the preceding 3 months; QTcB and/or QTcF > 480 msec or QTcB and/or QTcF ≥ 500 msec with old BBB. Patients with a potential risk for Torsades des Pointes should not be enrolled.
- Uncontrolled hypercoagulation.
- Life expectancy less than 2 years due to concomitant illnesses.
- In the opinion of the Investigator, the subject is unsuitable for cellular therapy.
- History of malignancy within 5 years except basal cell or squamous cell carcinoma of the skin or remote history of cancer now considered cured or positive Pap smear with subsequent negative follow-up.
- History of hypersensitivity to any of the components of the product formulation (including bovine or porcine products, dextran 40, and dimethyl sulfoxide [DMSO]).
- Disorders or allergies precluding the use of radiographic contrast or renal insufficiency severe enough to contraindicate the use of radiographic contrast.
- 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.
- Subject has received previous gene or cell therapy.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22908-0709
UCLA
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53792
Complete Family Foot Care - McAllen Office
McAllen, Texas, 78501-2930
Vascular Surgeon
Minneapolis, Minnesota, 55407
Dr. Wiliam M. Scholl College of Podiatric Medicine
North Chicago, Illinois, 60064
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
VA Palo Alto health
Palo Alto, California, 94304
Carl T. Hayden Veterans Affairs Medical Center
Phoenix, Arizona, 85012
Endeavor Clinical Trials PA
San Antonio, Texas, 78229
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
About this study
Official title: A Phase 1 Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
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).
Read the detailed description
The purpose of this Phase 1 study was to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of PDA-002, a human placenta-derived cell therapy, administered by intramuscular injection in subjects with peripheral arterial disease (PAD) and diabetic foot ulcers (DFU). This was a multicenter, open-label, 3+3 dose-escalation study. Subjects received PDA-002 administered intramuscularly on Study Days 1 and 8 at 1 of 4 planned dose levels ranging from 3 × 10^6 to 100 × 10^6 cells. Dose escalation proceeded after review of safety data from previously enrolled subjects. Subjects were followed for safety assessments for up to 24 months.
- Conditions
- Peripheral Arterial Disease, Diabetic Foot Ulcer
- Being tested
- PDA-002
- Keywords
- Peripheral arterial disease, diabetic foot ulcer, PAD, DFU
- Medical subject headings
- Peripheral Arterial Disease, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDA-002Biological
Human placenta-derived cells administered intramuscularly on Study Days 1 and 8.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: PDA-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through Day 15 following initial dosing
Treatment-Emergent Adverse Events (TEAEs)
Number of participants with treatment-emergent adverse events following administration of PDA-002.
Measured: From first dose through month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study start23 May 2013
- Primary completion1 Oct 2016
- Study completion14 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celularity Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- sharmila koppisetti, MD, Study director, Celularity Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859117
- Sponsor's protocol ID
- CCT-PDA-002-DFU-001
- Status last verified
- May 2026
- First submitted
- 17 May 2013
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28133924Francki 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.
PubMed 26054585
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01859117
- Acronym / sponsor ID
- CCT-PDA-002-DFU-001
- Conditions
- Peripheral Arterial Disease, Diabetic Foot Ulcer
- Keywords
- Peripheral arterial disease, diabetic foot ulcer, PAD, DFU
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Celularity IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 23 May 2013 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 14 Mar 2017 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Posted 4 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The purpose of this Phase 1 study was to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of PDA-002, a human placenta-derived cell therapy, administered by intramuscular injection in subjects with peripheral arterial disease (PAD) and diabetic foot ulcers (DFU). This was a multicenter, open-label, 3+3 dose-escalation study. Subjects received PDA-002 administered intramuscularly on Study Days 1 and 8 at 1 of 4 planned dose levels ranging from 3 × 10^6 to 100 × 10^6 cells. Dose escalation proceeded after review of safety data from previously enrolled subjects. Subjects were followed for safety assessments for up to 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3 x10^6 cells | Experimental | Biological: PDA-002Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 3 × 10^6 cells. |
| 10 x 10^6 cells | Experimental | Biological: PDA-002Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 10 × 10^6 cells. |
| 30 x 10^6 cells | Experimental | Biological: PDA-002Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 30 × 10^6 cells. |
| 100 x 10^6 cells | Experimental | Biological: PDA-002Subjects received PDA-002 (human placenta-derived cells) administered intramuscularly on Study Days 1 and 8 at a dose level of 100 × 10^6 cells. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must satisfy the following criteria to be enrolled in the study:
Key exclusion criteria (28 listed)
- The presence of any of the following will exclude a subject from enrollment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDA-002Human placenta-derived cells administered intramuscularly on Study Days 1 and 8. | Biological | 10 x 10^6 cells, 100 x 10^6 cells, 3 x10^6 cells, 30 x 10^6 cells |
Primary outcome
Dose Limiting Toxicity (DLTs)
Time frame: Through Day 15 following initial dosing
Number of participants with dose-limiting toxicities following intramuscular administration of PDA-002. Dose-limiting toxicity was used to evaluate maximum tolerated dose.
Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose through month 24
Number of participants with treatment-emergent adverse events following administration of PDA-002.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28133924Wu 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.
- Derived from this study: PubMed 26054585Francki 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.
- publicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sharmila koppisetti, MD study director
Celularity Incorporated
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PDA-002 in people with Peripheral Arterial Disease and Diabetic Foot Ulcer, run by Celularity Incorporated at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLTs) (time frame: Through Day 15 following initial dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859117, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.