Trial Search Results
Efficacy and Safety of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With and Without Peripheral Arterial Disease
The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo controlled, dose range finding study. The study will enroll approximately 133 subjects in four treatment groups. The primary objective of the study is to assess the efficacy and safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with and without PAD. The secondary objective is to explore potential clinical efficacy by assessing changes in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI), Transcutaneous oxygen measurements (TcPO2).
Stanford is currently accepting patients for this trial.
- Biological: 3 x 10^6 cells
- Biological: 10 x 10^6 cells
- Biological: 30 x 10^6 cells
- Other: Placebo
1. Males and females, at least 18 years of age or older at the time of signing the
informed consent document.
2. Understand and voluntarily sign an informed consent document prior to any study
related assessments/procedures are conducted.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Diabetes mellitus Type 1 or Type 2.
5. 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
6. No planned revascularization or amputation over the next 3 months after Screening
visit, in the opinion of the Investigator.
7. Screening should not begin until at least 14 days after a failed reperfusion
intervention and at least 30 days after a successful reperfusion intervention.
8. Subjects should be receiving appropriate medical therapy for hypertension and diabetes
any other chronic medical conditions for which they require ongoing care.
9. 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.
10. 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.
1. Any significant medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from participating in the study.
2. 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.
3. Any condition that confounds the ability to interpret data from the study.
4. Pregnant or lactating females.
5. Subjects with a body mass index > 45 kg/m2 at Screening.
6. AST (SGOT) or ALT (SGPT) > 2.5 x the upper limit of normal (ULN) at Screening.
7. Patient on renal dialysis for abnormal kidney function.
8. An ABI < 0.4 and or TBI < 0.3 in the leg with the index ulcer.
9. Bilirubin level > 2 mg/dL (unless subject has known Gilbert's disease) at Screening.
10. 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
11. 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
12. Index ulcer that has decreased or increased in size by ≥ 30% during the
Screening/Run-In/ Pre-Treatment Period.
13. Active Charcot Neuroarthropathy in the foot with the index ulcer
14. Pain at rest due to limb ischemia.
15. 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).
16. Poorly controlled diabetes mellitus (hemoglobin A1c > 12% or a screening serum glucose
of ≥ 300mg/dl).
17. Untreated proliferative retinopathy.
18. History of malignant ventricular arrhythmia, CCS Class III-IV angina pectoris,
myocardial infarction/ percutaneous coronary intervention (PCI) / coronary artery
bypass graft (CABG) in the preceding 6 months prior to signing the informed consent
form (ICF), pending coronary revascularization in the following 3 months, transient
ischemic attack/cerebrovascular accident in the preceding 6 months, prior to signing
the ICF, and/or New York Heart Association [NYHA] Stage III or IV congestive heart
19. Abnormal ECG: new right bundle branch block (BBB) ≥ 120 msec in the preceding 3 months
prior to signing the ICF.
20. Uncontrolled hypercoagulation syndrome.
21. Life expectancy less than at 2 years at the time of signing the ICF due to concomitant
22. In the opinion of the Investigator, the subject is unsuitable for cellular therapy.
23. History of malignancy within 5 years prior to signing the ICF 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.
24. History of hypersensitivity to any of the components of the product formulation
(including bovine or porcine products, dextran 40, and dimethyl sulfoxide [DMSO]).
25. 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
26. Subject has received previous investigational gene or cell therapy.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study