Stem cell trick may let kidney patients ditch daily pills

NCT ID NCT00619528

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving donor stem cells and a drug called Campath-1H can help kidney transplant recipients stop taking anti-rejection medications permanently. Eighty-eight patients receiving a kidney from an identical sibling will get the stem cell infusions and temporary immunosuppression. The goal is to see if the body accepts the new kidney without needing lifelong drugs, with follow-up lasting up to 10 years.

What this could mean

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

Active substance
donor hematopoietic stem cells and Campath-1H
What this could lead to
If successful, this could allow kidney transplant recipients to stop taking lifelong immunosuppressive drugs without rejecting the new kidney.
What could go wrong
This is an early-stage study with only 88 participants, and not all patients may achieve drug-free tolerance. There are risks of infection, graft rejection, or side effects from the conditioning regimen.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

88 people

The number who actually took part.

Started

Jan 2008

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patient fully informed, signed dated Institutional Review Board (IRB)-approved informed consent form obtained directly by the P.I., Co-P.I., or Res. Nurse, and willing to follow study procedures for the duration of study (3 yrs). * Recipient: a hematocrit of ≥ 33%, and a hemoglobin of ≥ 11.0 g/dL. * Weight \> 40 kg. * Primary renal allograft: living related (HLA-identical donor-recipient sibling pairs) * Negative B-cell and T-cell cytotoxic cross-match, and a low (≤ 10%) Panel Reactive Antibody (PRA) using cytotoxicity. * Women of childbearing potential: negative qualitative serum pregnancy test. * Patients studied equivalently as available for transplant using criteria, w/out regard to gender, race, or ethnicity. * Normal echocardiogram w/ ejection fraction \>50%. * Male participants w/ reproductive potential agree to use approved methods of birth control during treatment w/ Campath-1H and for minimum of 6 months following last dose. Female participants of childbearing potential agree to use approved methods of birth control for duration of participation in study. * Patient agrees to follow-up every 2 months after year 3, up to 10 years. Exclusion Criteria: * Patient previously received/receiving transplant other than kidney. * Patient receiving ABO (blood type) incompatible donor kidney. * Recipient/donor is ELISA positive for human immunodeficiency virus (HIV), antibody positive for hep. C, or surface antigen positive for hep. B. * Patient has current malignancy or history of malignancy (within past 5 years), except non-metastatic basal or squa¬mous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been treated successfully. * Patients w/ significant liver disease, defined as having during past 28 days continuously elevated aspartate aminotransferase (AST (SGOT)) and/or Alanine Aminotransferase (ALT (SGPT)) levels greater than 3 times the upper value of the normal range at this center. * Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer or other unstable medical condition that could interfere w/ study objectives. * Patient currently receiving investigational drug or received an investigational drug within 30 days pre-transplant. * Patient currently receiving immunosuppressive agent. * In investigator's judgment, anticipated that patient unable to take medications orally or via nasogastric tube by morning of second day (i.e., skin closure). * Concurrent use of warfarin, fluvastatin, astemizole, pimozide, cisapride, terfenadine, or ketoconazole. * Patient hypersensitivity to tacrolimus, Campath-1H, Thymoglobulin, daclizumab (Zenapax®), sirolimus, MMF or corticosteroids. * Patient pregnant or lactating. * Patients w/ screening/baseline total white blood cell count \<4000/mm3; platelet count \<100,000/mm3; fasting triglycerides \>400 mg/dl (\>4.6 mmol/L); fasting total cholesterol \>300 mg/dl (\>7.8 mmol/L); fasting HDL-cholesterol \<30 mg/dl; fasting LDL-cholesterol \>200 mg/dl. * Patient unlikely to comply w/ visits. * Patient w/ any form of substance abuse, psychiatric disorder or condition that, in investigator's opinion, may invalidate communication. * Expected that tacrolimus cannot be instituted for over 5 days post-operatively. * Patients w/ cytotoxic PRA value \>10% any time pre-enrollment. * Patients w/ Graves disease, unless previously treated w/ radioiodine ablative therapy. * History of idiopathic thrombocytopenic purpura (ITP) or thrombotic thrombocytopenic purpura (TTP)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

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