Placenta power: could donor cells heal diabetic foot wounds?

NCT ID NCT02264288

Disease control Sponsor: Celularity Incorporated Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether injections of cells from donated human placentas can help heal foot ulcers in people with diabetes. The trial includes patients with and without peripheral artery disease, a common complication that slows healing. Participants receive either the cell treatment or a placebo, and researchers track wound closure over three months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: human placenta-derived cells (PDA-002)
What this could lead to: If it works, this could offer a new way to heal stubborn diabetic foot ulcers, especially for those with poor blood flow.
What could go wrong: This is a mid-stage trial, so results are not yet proven. The treatment may not work better than placebo, and there could be unknown side effects from the cell injections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

159 people

The number who actually took part.

Started

Oct 2014

Finished

Feb 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 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: 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 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.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot Peripheral arterial disease

Contacts and locations

Locations

1Foot 2Foot Centre for Foot & Ankle Care PC

Suffolk, Virginia, 23434, United States
Advanced Foot & Ankle Center

Salt Lake City, Utah, 84102, United States
Animas Foot and Ankle

Durango, Colorado, 81301, United States
Arizona Arthritis and Rheumatology Research, PLLC

Phoenix, Arizona, 85023, United States
Bert J Altmanshofer and associates, LTD

Duncansville, Pennsylvania, 16635, United States
CGH Medical Center Main Clinic

Sterling, Illinois, 61081, United States
Cardiology PC

Birmingham, Alabama, 35211, United States
Carilion Clinic

Roanoke, Virginia, 24013, United States
Carl T. Hayden Veterans Affairs Medical Center

Phoenix, Arizona, 85012, United States
Center for Clinical Research Inc.

San Francisco, California, 94115, United States
Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida, 33765, United States
Endeavor Clinical Trials PA

San Antonio, Texas, 78229, United States
Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States
Florida Research Network, LLC

Gainesville, Florida, 32605, United States
Foot and Ankle Center of Illinois

Springfield, Illinois, 62704, United States
Foot and Ankle Clinic

Los Angeles, California, 90057, United States
Futuro Clinical trials

McAllen, Texas, 78501-2930, United States
GF Professional Research Group Corporation

Miami Lakes, Florida, 33016, United States
Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia, 20007-2197, United States
Hamilton Foot Care

Baltimore, Maryland, 21214, United States
Jeffrey A Klemes DPM

Beverly Hills, California, 90211, United States
Limb Preservation Platform, INC.

Fresno, California, 93720, United States
Milwaukee Foot & Ankle Specialists

Wauwatosa, Wisconsin, 53226, United States
NEA baptist clinic

Jonesboro, Arkansas, 72401, United States
Northwest Hospital

Randallstown, Maryland, 21133, United States
Ocean City Foot and Ankle Assoc

Toms River, New Jersey, 08753, United States
Office of Michael J. De Marco, DPM

Newark, New Jersey, 07102, United States
Podiatry 1st

Belleville, Illinois, 62226, United States
Premier Vein and Vascular Center

Houston, Texas, 77084, United States
Reliance Clinical Research

Chino, California, 91710, United States
Revive Research Institute

Sterling Heights, Michigan, 48313, United States
Rosalind Franklin University of Medicine and Science

North Chicago, Illinois, 60064, United States
SAM Clinical Research Center

San Antonio, Texas, 78229, United States
Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States
Solutions Through Advanced Research Inc.

Jacksonville, Florida, 32258, United States
Stanford University

Stanford, California, 94063, United States
Swagel wootoon hiatt eye center

Mesa, Arizona, 85206, United States
The Research Center

Hialeah, Florida, 33012, United States
UNC Hospitals University of North Carolina

Chapel Hill, North Carolina, 27599-7010, United States
University of Florida

Jacksonville, Florida, 32209, United States
University of Miami

Miami, Florida, 33136, United States
University of Pennsylvania Health Systems

Philadelphia, Pennsylvania, 19104, United States
VA Palo Alto Health Care System

Palo Alto, California, 94304, United States
Weill Foot & Ankle Institute

Des Plaines, Illinois, 60016, United States
Well Pharma Medical Research Corporation

Miami, Florida, 33143, United States

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