CD34+ Cell Enriched and T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Mismatched Related Donors or Borderline Organ Function
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ClinicalTrials.gov Identifier: NCT02162511 |
Recruitment Status : Unknown
Verified May 2015 by Rajni Agarwal, Stanford University.
Recruitment status was: Recruiting
First Posted : June 12, 2014
Last Update Posted : May 21, 2015
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Condition or disease | Intervention/treatment | Phase |
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Malignant Diseases Non-malignant Diseases | Device: CliniMACS CD34+ cell enrichment and T-cell depletion | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Expanded Access Study Using the CliniMACS System to Offer Therapeutic Manipulated Grafts That Are CD34 Cell Enriched and T Cell Depleted for Allogeneic Stem Cell Recipients With Mismatched Related Donors or Borderline Organ Function |
Study Start Date : | May 2014 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2020 |
Arm | Intervention/treatment |
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Experimental: ARM A Malignant TBI
Malignant diseases Conditioning including total body irradiation and chemotherapy
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Device: CliniMACS CD34+ cell enrichment and T-cell depletion |
Experimental: ARM B Malignant Non-TBI
Malignant diseases chemotherapy based conditioning
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Device: CliniMACS CD34+ cell enrichment and T-cell depletion |
Experimental: ARM C Non-malignant
Non-malignant diseases Chemotherapy based conditioning
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Device: CliniMACS CD34+ cell enrichment and T-cell depletion |
- Incidence of severe (Grade III/IV) acute graft versus host disease [ Time Frame: Day 100 post transplant ]

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Ages Eligible for Study: | up to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant age is 0 (newborn) to 35 years-old.
- Participant has a disorder affecting the hematopoietic system that are inherited, acquired, or a result from the myeloablative treatment that can benefit from alternative stem cell transplantation according to standard practice guidelines for including patients for transplant.
- Participant's medical screening clears s/he for allogeneic transplantation as per current institutional SOP based on standards of foundation for accreditation of cellular therapy and stem cell transplantation (FACT);
- Participant must lack a healthy, HLA-identical related or unrelated donor unless s/he has a borderline organ function that will preclude the recipient from receiving a curative therapy due to the need of post-HSCT immunosuppressive therapy.
- Participant must have a matched or mismatched-related donor who is:
- Able to receive granulocyte colony-stimulating factor (G-CSF) and undergo apheresis either through placement of catheters in antecubital veins or a temporary central venous catheter OR agrees on a bone marrow harvest;
- Healthy as per donor selection screening (following current SOP based on standards of foundation for accreditation of cellular therapy and stem cell transplantation - FACT);
- Willing to participate and sign consent.
- Participant or Legal Authorized Representative is able to sign informed consent (and signed assent, if applicable) for transplant.
Exclusion Criteria:
- Participant does not qualify for an allogeneic transplant due to medical screening, underlying disease, or lack of alternative donors.
- Any condition that compromises compliance with the procedures of this protocol, as judged by the principal investigator.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162511
United States, California | |
Stanford Children's Hospital | Recruiting |
Palo Alto, California, United States, 94305 | |
Contact: Rajni Agarwal, MD 650-725-9250 | |
Contact: Leigh Shinn, RN 650-724-9179 | |
Principal Investigator: Rajni Agarwal, MD |
Principal Investigator: | Rajni Agarwal, MD | Stanford University |
Responsible Party: | Rajni Agarwal, Principal Investigator, Stanford University |
ClinicalTrials.gov Identifier: | NCT02162511 |
Other Study ID Numbers: |
28663 |
First Posted: | June 12, 2014 Key Record Dates |
Last Update Posted: | May 21, 2015 |
Last Verified: | May 2015 |
Haplocompatible Stem cell transplant Borderline organ function Alternative donor stem cell transplant |