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Cell Therapy

Infusion of Donor Hematopoietic Stem Cells and Campath-1H for Kidney Transplant

N/A

Waitlist Available

Led By Joshua Miller, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post-transplant

Awards & highlights

Study Summary

This trial is testing whether donor stem cells can be used to stop a recipient's body from rejecting a transplanted kidney from the same donor, without the use of immunosuppressive drugs.

Eligible Conditions

Kidney Transplant
Immunosuppression
Transplant Rejection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient and graft survival measured at the one-year timepoint post-transplant.

The ability to withdraw immunosuppression as above 24 months post-transplant with follow-up to 10 years.

Secondary outcome measures

Incidence of adverse events associated w/ renal transplantation and immunosuppression, including infections, malignancies, post transplant lymphoproliferative disease (PTLD), thromboembolic events, hyperlipidemia, leukopenia, thrombocytopenia, GI toxic

Incidence of chronic allograft nephropathy, determined using renal biopsies and laboratory values, including 24 hour urine protein excretion.

Incidence of graft versus host disease (GVHD).

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

No separate arms: All Enrolled Receive Same Treatment

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

917,021 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,273 Total Patients Enrolled

Joshua Miller, MDPrincipal InvestigatorNorthwestern University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What sort of participants are most suitable for this clinical study?

"This study seeks out 230 candidates aged 18-65 who have had rejection or transplant operations. To qualify, individuals need to meet the following specifications: Hematocrit of no less than 33% and hemoglobin of 11 g/dL; living related HLA-identical donor - recipient sibling pairs; informed consent delivered in person by principal investigators or research nurses; weight greater than 40 kgs; negative B and T cell cytotoxic crossmatch with PRA lower than 10%; a pregnancy test verifying that women are not pregnant at the time of screening (if applicable); equal consideration given to all races, genders, ethnicities when assessing"

Answered by AI

What is the aggregate cohort size in this medical study?

"This trial is no longer accepting patients. It was first posted on July 1st 2007, and the last updates were made on May 22nd 2020. Fortunately, there are 117 other clinical trials for transplant rejection currently recruiting participants as well as 33 studies involving Campath-1H infusions that are similarly enrolling volunteers."

Answered by AI

What are the results of other research initiatives involving Injection of Donor Hematopoietic Stem Cells and Campath-1H?

"Presently, 33 separate clinical trials are investigating Infusion of Donor Hematopoietic Stem Cells and Campath-1H. Out of those 33 studies, 3 have progressed to Phase 3 with the largest concentration located in Philadelphia, Pennsylvania. Across the United States there are 230 sites running clinical trials on this subject matter."

Answered by AI

What condition is Infusion of Donor Hematopoietic Stem Cells and Campath-1H most commonly employed to remedy?

"Multiple sclerosis can be treated with the infusion of donor hematopoietic stem cells and Campath-1H. This therapy has also been demonstrated to help people struggling with rejection, transplantation issues, kidney disease, B lymphocyte diseases like leukemia and T cell chronic illnesses."

Answered by AI

Are further participants being sought for this investigation?

"This medical trial has been inactive since May 22nd 2020, when the last update was made. If you are interested in alternative studies, there is currently a plethora of research programs actively recruiting; 117 trials for transplant rejection and 33 infusion-based stem cell studies utilizing Campath-1H as a therapy."

Answered by AI