Yoshifumi Naka, MD, PhD

New-York Presbyterian/Columbia University is participating in a trial that is evaluating the use of human bone-marrow (Mesenchymal) derived stem cells (AC607), for the treatment of acute kidney injury (ACT-AKI). Naka, Yoshifumi, MD,PhD, Professor of Surgery and Director of both the Cardiac Transplantation Program and the Mechanical Circulatory Support Program is the principle investigator for the study sponsored by AlloCure, Inc (Burlington, MA).

What is the ACT-AKI clinical trial?

ACT-AKI is a randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the safety and efficacy of AC607 in cardiac surgery subjects who have laboratory evidence of post-operative acute kidney injury (AKI). AlloCure will enroll approximately 200 cardiac surgery subjects at leading tertiary care centers in the United States.

What are the effects of AKI?

AKI is a relatively common condition and is often associated with serious consequences. Recent epidemiologic assessments indicate that approximately 5 to 7% of all hospitalized patients may develop some degree of AKI. Moreover, when AKI occurs, the complications are potentially catastrophic both from patient and health-economic perspectives. AKI is associated with significantly increased in-hospital morbidity, mortality, and associated costs. While there have been a number of strategies evaluated for the treatment of AKI, no effective therapies are available beyond supportive measures including dialysis. AlloCure’s innovative cell therapy, AC607, offers the potential for improving outcomes in patients afflicted with this serious condition.

How is AC607 manufactured?

The human mesenchymal stem cells (MSC) used to formulate AC607 are derived and expanded from bone marrow obtained from healthy adult donors using a proprietary and mature state-of-the-art manufacturing process. These cells possess unique characteristics that make them ideal as a potential therapeutic including:

      • Immune privileged – avoids detection by the patient’s immune system
      • No donor matching – administered as an off-the-shelf product, obviating the need for blood or tissue typing
      • Genetically stable – not transformed or induced

What are the potential benefits of AC607 in treating AKI?

MSCs Mediate Pro-Angiogenic

AlloCure has conducted extensive non-clinical studies demonstrating that the administration of allogeneic MSC prior to or after the development of AKI effectively enhances kidney repair and improves survival. These studies demonstrated that following AKI, the damaged kidney expresses increased levels of stromal-cell derived factor 1 (SDF-1). SDF-1 acts as a homing signal for MSC, bringing them to the site of injury to carry out their function. After reaching the injured kidney, MSC mediate anti-inflammatory and organ repair processes via the secretion of beneficial paracrine (cell to cell communication) factors, including vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factor 1 (IGF-1) and others, which instruct the local damaged kidney cells to divide and survive rather than undergo apoptosis (cell death) and subsequent fibrosis. Notably, MSC are in residence in the injured kidney for only a short period of time and do not differentiate and re-populate the injured organ. The paracrine mediators produced by the stem cells act to preserve and restore kidney function following AKI via several mechanisms, including:

      • Anti-apoptotic (preventing existing cells from dying)
      • Mitogenic (promoting cellular reproduction)
      • Anti-inflammatory
      • Angiogenic (promoting vascularization of the tissue)

Due to these unique qualities, AC607 represents a promising approach for the treatment of AKI.

“The occurrence of AKI in patients undergoing cardiac surgery often has critical and costly consequences, yet we are still lacking approved remedies other than supportive care,” according to Dr. Naka. “AC607 has the potential to become that remedy, and the ACT-AKI Trial is moving this field in the right direction.”

For more information about the ACT-AKI trial or other clinical trials at New-York Presbyterian/Columbia University, please visit our clinical trials homepage.


Save the Date: Sharing Life Day

by Columbia Surgery on April 7, 2013

Reserve your place at the Transplant Forum April 28, 2013.

Has your life been touched in any way by organ transplantation?

If so, you may already appreciate that every organ transplant is made possible by unprecedented collaboration among scores of people. Obvious contributors include the surgeons, physicians, and nurses who perform organ transplantation every day. Their work is made possible by the teams of researchers who spend their careers working to better understand the immune functions involved in organ transplantation, improve care for patients, and develop new surgical techniques. There are the organ donors and their families, the often unsung, even anonymous heroes without whose selfless acts organ transplantation would cease to exist. There are the patient’s friends and others whose support is crucial to the success of their transplant surgery. And in the center of it all, the patients themselves, whose lives are forever transformed by all that these people have been able to accomplish on their behalf.

Not often do these parties have the opportunity to come together to celebrate, learn, and make a difference.

That is one of the special things about Sharing Life Day, a special event hosted by the Transplant Forum at Columbia University Medical Center on Sunday, April 28, 2013.


Another very special feature is the opportunity to hear about the latest in the field firsthand, in an informal setting, from some of the world’s foremost experts in transplant medicine.

This event will be a celebration of organ donors and recipients, their families and friends, and the doctors, nurses and medical staff who devote their efforts to this life-saving work. It will include an interactive panel discussion with experts in organ transplantation, featuring Columbia faculty who specialize in different areas of transplantation, on the ground-breaking work that will change the future of transplant. There will be family-friendly activities and a celebratory lunch with personal stories from patients and family members whose lives were touched by transplantation. Guests will also have the opportunity to learn more about how they can make a difference in advancing research and organ donation.

All are welcome to attend; the event is open to the public, but RSVP is required.

    Event details:
    Sunday, April 28, 2013
    11 am – 2 pm
    Family-friendly lunch and children’s activities will be provided.

    Information and reservations: Please contact William Devers
    Telephone: 212.304.7222


Calcium Supplementation: More May Not be Better

March 21, 2013

TweetCalcium supplementation is necessary for many health conditions, such as osteoporosis, kidney failure, and parathyroid dysfunction. In older individuals, calcium supplementation may help prevent the risk of bone fracture, which can seriously impact overall health and increase the risk of death. If you are under the care of a health care provider who has recommended […]

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Show Your Love: Feb. 14 is National Organ Donor Day

February 14, 2013

TweetEveryone knows today is Valentine’s Day; you may even be in a chocolate coma by now, or enjoying the delicious fragrance of flowers from your sweetheart.  But did you also know that it is National Organ Donor Day? National Organ Donor Day recognizes another kind of love: the truly selfless, altruistic act of giving the […]

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Waiting for a Kidney Transplant? Your chances for transplant could soon improve.

October 19, 2012

Tweet The United Network for Organ Sharing, UNOS, the non-profit organization responsible for allocating donor organs to patients waiting for transplantation, is proposing a new system to determine how kidneys are distributed.* If approved during a vote in the spring of 2013, this proposal will represent the first major overhaul of the national kidney allocation […]

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“To Be or Not to Be”… an Organ Donor

August 28, 2012

TweetArundi Mahendran, MBBS, MRCS, MSc is a transplant surgeon and accomplished singer. Originally from London, Dr. Mahendran completed her general surgery residency at University College London and a fellowship in abdominal transplant surgery at NewYork-Presbyterian Hospital. A recent episode of NY Med followed Dr. Mahendran as she collaborated on a living donor liver transplantation in […]

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Anthony Watkins, MD: Mission to Haiti

July 30, 2012

TweetIn late June this year Anthony Watkins MD, a surgeon in the Kidney and Pancreas Transplant Surgery Program at New York-Presbyterian Hospital/Columbia, traveled to Haiti as part of a humanitarian mission. He volunteered with the New York Chapter of the National Organization for Advancement of Haitians (NOAH) and the Haitian American Alliance (HAA), under the […]

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New Study May Hold Promise for Kidney Transplant Patients

June 25, 2012

TweetNewYork-Presbyterian Hospital/Columbia University Medical Center is in the middle of a study called “Controlled, Randomized, Prospective, Double-Blind, Multi-Center, Phase I/II, Dose-Escalation Study of the Safety, Pharmacokinetics, and Clinical Activity of 15NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation.” Excuse me? In plain English, doctors at multiple national and international […]

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Experts Debate Uniting Kidney Exchange Agencies into Single National Registry

June 11, 2012
Thumbnail image for Experts Debate Uniting Kidney Exchange Agencies into Single National Registry

TweetThe field of kidney transplant surgery is evolving in dramatic ways thanks to the advent of paired exchanges, or ‘kidney swaps.’ During a kidney swap, transplant recipients who have willing live donors essentially swaps donor organs. For patients who have a willing but incompatible donor, the strategy allows people who need a kidney to receive […]

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National Cancer Survivors Day

June 1, 2012

TweetSunday, June 10, 2012 · 1:00 to 5:00 pm NewYork-Presbyterian Hospital/Columbia University Medical Center 173 Fort Washington Avenue, New York, NY 10032 Vivian and Seymour Milstein Family Heart Center A Cancer Survivor is Anyone Who has Been Diagnosed with Cancer Whether you’re in treatment, just diagnosed, or have been in remission for 20 years, you’re […]

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