Efficacy and Safety of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With and Without Peripheral Arterial Disease
NCT ID: NCT02264288
Last Updated: 2020-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
159 participants
INTERVENTIONAL
2014-10-23
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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3 x 10^6 cells
Human Placenta Derived cells (PDA-002) administered intramuscularly (IM) on Study Days 1 and 8
3 x 10^6 cells
3 x 10\^6 cells administered on Study Days 1 and 8
10 x 10^6 cells
10 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
10 x 10^6 cells
10 x 10\^6 Human Placenta Derived cells (PDA-002) administered on Study Days 1 and 8
30 x 10^6 cells
30 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
30 x 10^6 cells
30 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
Placebo
Identically matching placebo administered IM on Study Days 1 and 8
Placebo
Identical matching placebo administered IM on Study Days 1 and 8
Interventions
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3 x 10^6 cells
3 x 10\^6 cells administered on Study Days 1 and 8
10 x 10^6 cells
10 x 10\^6 Human Placenta Derived cells (PDA-002) administered on Study Days 1 and 8
30 x 10^6 cells
30 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
Placebo
Identical matching placebo administered IM on Study Days 1 and 8
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 the investigator.
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.
Exclusion Criteria
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 with IP.
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 resection.
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 failure.
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 illnesses.
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 study.
26. Subject has received previous investigational gene or cell therapy.
18 Years
ALL
No
Sponsors
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Celularity Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Solveig Ericson, MD
Role: STUDY_DIRECTOR
Celularity Incorporated
Locations
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Cardiology PC
Birmingham, Alabama, United States
TFi Medical
Mobile, Alabama, United States
East Valley Foot and Ankle Specialist
Mesa, Arizona, United States
Carl T. Hayden Veterans Affairs Medical Center
Phoenix, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, United States
Aung Foothealth Clinics and Advanced Wound Care Center
Tucson, Arizona, United States
Northeast Arkansas Baptist Clinic
Jonesboro, Arkansas, United States
Jeffrey A Klemes DPM
Beverly Hills, California, United States
Center for Clinical Research Inc.
Castro Valley, California, United States
Reliance Clinical Research
Chino, California, United States
Limb Preservation Platform, INC.
Fresno, California, United States
Foot and Ankle Clinic
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
Stanford University
Stanford, California, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, United States
Barry University
Fort Lauderdale, Florida, United States
Florida Research Network, LLC
Gainesville, Florida, United States
The Research Center
Hialeah, Florida, United States
University of Florida
Jacksonville, Florida, United States
Solutions Through Advanced Research Inc.
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Well Pharma Medical Research Corporation
Miami, Florida, United States
GF Professional Research Group Corporation
Miami Lakes, Florida, United States
Med-Care Research Inc
North Miami Beach, Florida, United States
Podiatry 1st
Belleville, Illinois, United States
University of Illinois at Chicago Cancer Center
Chicago, Illinois, United States
Weill Foot & Ankle Institute
Des Plaines, Illinois, United States
Rosalind Franklin University of Medicine and Science
North Chicago, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Foot and Ankle Center of Illinois
Springfield, Illinois, United States
CGH Medical Center Main Clinic
Sterling, Illinois, United States
Hamilton Foot Care
Baltimore, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Northwest Hospital
Randallstown, Maryland, United States
Revive Research Institute
Sterling Heights, Michigan, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Office of Michael J. De Marco, DPM
Tinton Falls, New Jersey, United States
Ocean City Foot and Ankle Assoc
Toms River, New Jersey, United States
Animas Foot and Ankle
Gallup, New Mexico, United States
Office of Gerard J. Furst, DPM, PLLC
East Setauket, New York, United States
Syracuse VA Medical Center
Syracuse, New York, United States
UNC Hospitals University of North Carolina
Chapel Hill, North Carolina, United States
Clinical Research Associates of Central Pennsylvania
Duncansville, Pennsylvania, United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Premier Vein and Vascular Center
Houston, Texas, United States
Complete Family Foot Care - McAllen Office
McAllen, Texas, United States
Endeavor Clinical Trials PA
San Antonio, Texas, United States
SAM Clinical Research Center
San Antonio, Texas, United States
Advanced Foot & Ankle Center
Salt Lake City, Utah, United States
Carilion Clinic
Roanoke, Virginia, United States
1Foot 2Foot Centre for Foot & Ankle Care PC
Suffolk, Virginia, United States
Milwaukee Foot & Ankle Specialists
Wauwatosa, Wisconsin, United States
Countries
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Other Identifiers
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CCT-PDA-002-DFU-002
Identifier Type: -
Identifier Source: org_study_id
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