Clinical Trials Logo

Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT02026934
Other study ID # 13-024
Secondary ID
Status No longer available
Phase N/A
First received January 2, 2014
Last updated November 18, 2016
Start date March 2013

Study information

Verified date November 2016
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial Summary

CliniMACs is an investigational device used to select and enrich stem cells. The device will select the stem cells with CD34+ protein. The participant will be infused with the CD34+ selected cells in the hopes that it will help the participant engraft. Engraftment is when transplanted stem cells resume production of healthy blood cells.


Description:

- After the screening procedures confirm that the participant is eligible to participate in the research study: If the participant takes part in this research study, the participant (and their donor) will have the following tests and procedures:

- Donor Graft Collection: The participant's cell donor will undergo stem cell collection. The cells collected will be sent to the laboratory for processing.

- Donor Graft Processing: In the laboratory the CliniMACS device will be used to separate the CD34+ stem cells from the other types of cells in the graft. After completing the necessary safety tests, the CD34+ selected donor graft will be ready for administration.

- Donor Graft Infusion: The CD34+ selected donor graft will be infused through an intravenous (I.V.) catheter. The day of this infusion is called Day 0.

- Follow-Up Visits: Approximately 3, 6 and 12 months after the donor graft infusion, the participant will return to clinic for follow-up visits. At each of the visits, the participant will have a physical exam and asked questions about your general health. The participant will also have routine blood tests performed (approximately 1 tablespoon of blood).

- At times more cells are collected from a donation than are needed to do the transplantation. If your physician determines that it is preferable to administer a dose of cells that is less than the complete collection, the extra cells may be frozen and stored in our freezers for the participant's future use. If the cell counts do not improve, the participant will be given the remaining cells through an intravenous (I.V.) catheter.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients aged >18 years

- Diagnosis is graft exhaustion.

- Ability to understand and willingness to sign a written informed consent document

- Matched related or unrelated donor must consent to provide an allograft.

Exclusion Criteria:

- Symptomatic or uncontrolled cardiac failure or coronary artery disease.

- Karnofsky performance status < 60%.

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Device:
CliniMACS CD34 Reagent System
Following screening and enrollment, peripheral blood or bone marrow collection will be performed on the donor followed by subsequent CD34+ cell selection using the Miltenyi CliniMACS device. There is no limit to the number of CD34+ progenitors that can be administered. The CD34+ selected cells will be infused within 12 hours of the initiation of processing.

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Joseph Antin Miltenyi Biotec GmbH

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Withdrawn NCT02312115 - Delayed Renal Allograft Function and Furosemide Treatment Phase 2
Completed NCT02134314 - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI Phase 1/Phase 2
Completed NCT02346968 - Evaluation of CAF22 After Renal Transplantation
Completed NCT01794663 - Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function Phase 2
Completed NCT00298181 - YSPSL for Prevention of Delayed Graft Function Part A Phase 1/Phase 2
Not yet recruiting NCT05166460 - Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation N/A
Recruiting NCT03071536 - Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation N/A
Not yet recruiting NCT05513807 - Graft Acute Kidney Injury: Vitamin B3 to Facilitate Renal Recovery In the Early Life of a Transplant Phase 3
Recruiting NCT04005469 - Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation Phase 1/Phase 2
Completed NCT01848249 - Deceased Donor Biomarkers and Recipient Outcomes
Active, not recruiting NCT02474667 - Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney Phase 3
Terminated NCT00217152 - A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors Phase 4
Recruiting NCT05430620 - Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys Phase 3
Completed NCT03864926 - Envarsus in Delayed Graft Function (E-DGF) Phase 4
Recruiting NCT06367205 - Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations N/A
Completed NCT02610296 - QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant Phase 3
Active, not recruiting NCT02568696 - Intra-graft Coagulation Events in Clinical Renal Transplantation and Delayed Graft Function
Recruiting NCT01837043 - Early Conversion From CNI to Belatacept in Renal Transplant Recipients With Delayed and Slow Graft Function Phase 2
Terminated NCT01878786 - A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys Phase 2/Phase 3
Active, not recruiting NCT01395719 - Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function N/A