TerminatedPhase 1

Hepatocyte Transplantation for Liver Based Metabolic Disorders

Stopped: seeking additional funding

United States5 participantsStarted 2011-03

Plain-language summary

The purpose of this research study is to determine whether partial irradiation of the liver and liver cell transplantation can provide help for patients with life-threatening liver-based metabolic diseases who are unlikely to survive without extensive medical therapy or transplant. The goal of this research study is to determine if liver cell transplants can be effective as an alternative to organ transplantation. At the present time, liver cell transplants are experimental and have been done in a limited number of human subjects.

Who can participate

Age range21 Years

SexALL

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Exclusion criteria

✕. Subject has active malignancy.
✕. Subject has allergy to immunosuppression medications that are required post transplant procedure for the prevention of rejection.
✕. Subject has sepsis, pneumonia, other active infection or other secondary life-threatening organ dysfunction.
✕. Significant liver fibrosis determined by biopsy (if clinically indicated). Significant liver fibrosis will be defined by the Ishak Staging, Stage 5: bridges with occasional nodules.
✕. Subject is pregnant or breastfeeding.

What they're measuring

Improvement in enzyme physiologic function at 6 months

Timeframe: 6 months post hepatocyte transplant

Trial details

NCT IDNCT01345578

SponsorIra Fox

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

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