Symptoms and General Pathology

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Blood and Lymph Conditions

Rare Diseases

Syndrome

Hematologic Neoplasms

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Myelodysplastic Syndromes

Primary Myelofibrosis

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Hematologic Diseases

Myeloproliferative Disorders

Chronic Myeloproliferative Disorders

Antineoplastic Agents

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All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Patients status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function will receive a CD34 selected hematopoietic stem cell infusion with or without preceding conditioning.

Fludarabine 25 mg/mq day 1 - 5 + 2 Gray Total body irradiation depending on clinician's discretion (with the addition of cyclophosphamide 14.5 mg/kg for two doses for haploidentical or matched unrelated donor with at least one major HLA mismatch). Recommendation to use a conditioning regimen include complete loss of donor chimerism, trilineage cytopenias.

CD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion

Infusion of CD34 selected hematopoietic stem cells

Antonio Di Stasi, M.D.

Chowdury Nazma

Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.

Patients eligible to be treated on this status are status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function (e.g. marrow cellularity reduced per age and/or dropping donor chimerism with cytopenias and/or platelets or red blood cells transfusion requirement).

Feasibility study of CD34 selection for graft versus host disease (GVHD) Prophylaxis using the automated CliniMACS Prodigy Device.

CD34 Selection Using the Automated CliniMACS Prodigy

Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS

Incidence of severe (grade III-IV) acute GVHD \<=25% at 100 days

Incidence of extensive chronic GVHD \<=10% at one year.

Clinical improvement, defined as an increase of blood counts with transfusion independence if anemia or thrombocytopenia or freedom for infections if reduced leukocytes

Rate of one-year non-relapse mortality (NRM).

University of Alabama at Birmingham

Associate Professor

Head and Neck Neoplasms

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

Prior to the split thickness skin graft (STSG) harvest, the tumescence technique will injection of 100-150 mL normal saline with 1:500,000 epinephrine injected into a deep dermal thigh tissue plane with 18-gauge spinal needle on a 60 mL syringe.

Patients randomized to "no tumescence" will have their free flap donor site reconstructed with a split thickness skin graft (STSG) harvested at 0.0175 inches using the dermatome to obtain a graft from the thigh.

Tumescence injections performed prior to STSG harvest

Tumescence During STSG Harvest

Marianne Abouyared, MD

Our primary objective is to determine if the use of tumescence has a meaningful effect on STSG uptake at the recipient site. This is an important outcome because poor graft uptake results in the need for prolonged local wound care, additional clinic visits for patients and increased risk of infection. A prospective, randomized comparison of the tumescence to our current standard of care will allow us to definitively evaluate any benefits to this technique.

Tumescence is commonly used in the treatment of burn patients to minimize blood loss during both tangential excision of eschar and during harvest of split-thickness grafts for reconstruction. This is considered the standard of care in burn surgery as using tumescence has been clearly demonstrated to reduce intraoperative blood loss during harvest of large skin grafts and excision of large burns when compared with the application of topical epinephrine as was the historic standard practice.4-6 Tumescence also creates a firm and uniform surface from which to harvest the skin graft, which the investigators believe may improve the quality of harvest and rate of skin graft take.

Multimodal treatment for head and neck cancer often includes surgical resection. Large tumors leave behind large anatomical defects when resected, which require reconstruction to rehabilitate form and function after ablative surgery. Two commonly used reconstructive options in reconstructive surgery are the radial forearm free flap and the fibula free flap. These in turn leave cutaneous defects at the donor site which must be reconstructed to protect the underlying soft tissues, muscles, and tendons exposed as a result of their harvest. This is effectively accomplished with a split thickness skin graft harvested from the thigh, which generally results in excellent coverage of the free flap donor site and minimal skin graft donor site morbidity. 1-3 Using a free flap for reconstruction following surgical tumor ablation often leaves behind a donor site that cannot be closed primarily and at our institution these defects are reconstructed using split-thickness skin grafts (STSG) harvested from the thigh. This creates an additional wound that must be carefully monitored, as poor skin graft take or failure can result in exposed muscle or tendon at the donor site. While many of these wound-healing complications can be treated with simple dressings, this can create added stress, another site of potential infection, and delayed healing and return to function.1-3 Tumescence of the skin graft harvest site involves a deep dermal infiltration of normal saline with epinephrine to the thigh prior to skin graft harvest. This has been demonstrated to minimize intraoperative blood loss4-6 and is routinely utilized in burn surgery where extensive skin grafting is often required.

The effect of tumescence on skin graft quality and take has not been evaluated. Anecdotally, it is our impression that this procedure may yield a lower graft failure rate thereby decreasing post-operative extremity immobility, risk of infection and wound care requirements.2 In this study, the investigators plan to compare the quality and take of split thickness skin grafts harvested with and without tumescence. Our results will have important implications for how split thickness skin grafting is performed in head and neck reconstructive surgery.

Participants will be masked to the randomization group. Investigators that will be reviewing the graft images will also be masked to the randomization group.

Tumescence in HNC Skin Graft Reconstruction

The Role Of Tumescence In Split Thickness Skin Grafting For Reconstruction Of Head And Neck Cancer Resection

IPD will not be shared with other researchers.

To assess the use of tumescence during STSG harvest affect graft take at the recipient site as measured by percentage of graft uptake as measured using ImageJ (open source software available from NIH) at one month post-operatively

To determine whether the location of the graft (radial forearm v fibula) affects the graft take.

To determine whether the size of the recipient site defect affect graft take.

To evaluate if comorbidities including smoking status affect skin graft take.

To evaluate if comorbidities including Diabetes affect skin graft take.

To evaluate if comorbidities including BMI affect skin graft take.

To evaluate if comorbidities including Peripheral Arterial Disease affect skin graft take.

University of California, Davis

Heart and Blood Diseases

Gland and Hormone Related Diseases

Wounds and Injuries

Neoplasm Metastasis

Myocardial Infarction

Infarction

Hyperparathyroidism

Hyperparathyroidism, Secondary

Fractures, Bone

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

iPTH at one year post transplantation below target range of iPTH by stage of CKD (KDOQI-guidelines).

iPTH at one year post transplantation within target range of iPTH by stage of CKD (KDOQI-guidelines).

iPTH at one year post transplantation above target range of iPTH by stage of CKD (KDOQI-guidelines).

Gunnar Sterner, MD A/Prof

Astrid Seeberger, PhD, A/Prof

Elin Isaksson, MD

The purpose of the study is to evaluate the long term vascular morbidity and mortality in kidney transplant recipients based on one year post transplant levels of intact parathyroid hormone.

Secondary hyperparathyroidism (SHPT) is a well known complication to chronic renal failure. With impaired renal function the phosphate excretion from the kidney is reduced. Together with low levels of 25- and 1,25-vitamin D3 and hypocalcemia this uremic mineral milieu drives the release of parathyroid hormone (PTH) and the development of SHPT. PTH has many functions but acts mainly to release calcium from the skeleton, to enhance calcium uptake from the intestines (by actions on vitamin D) and to lower serum phosphate by inducing phosphaturia. SHPT has been shown to cause vascular morbidity and fractures in the chronic kidney disease (CKD) patient. After successful renal transplantation (RT) the mineral disturbances are mostly recovered and stabilized at one year post RT, but in recent years it has been shown that SHPT persists in the major part of RT-recipients even after long term follow up. This has been associated with high risk of fractures and vascular related morbidity in the post transplant period. It has also been shown that low levels of iPTH in the post-transplant period might be associated with a high risk of fractures. Because of insufficient data on PTH levels and associated morbidity there is no specific recommendations of target PTH levels in the RT-patient. This indicates that there is need for further observational studies to describe the SHPT-associated morbidity in a post transplant cohort based on stabilized levels of post transplant iPTH.

Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation

Secondary Hyperparathyroidism Related Vascular and Bone Morbidity After Renal Transplantation - a 6 Year Follow up Retrospective Cohort Study.

Vascular events defined as (Myocardial infarction, Stroke, Peripheral Vascular Occlusion)

Start in Active Uremic Treatment (dialysis, renal transplantation)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CD34 Selection Using the Automated CliniMACS Prodigy	NCT06047886	AML ALL Lymphoid Malign... Myelodysplastic... CML Primary Myelofi...	Infusion of CD3...	4 Weeks - 75 Years	University of Alabama at Birmingham
Tumescence in HNC Skin Graft Reconstruction	NCT04967391	Head and Neck C... Surgery--Compli... Graft Failure	Tumescence Duri...	18 Years -	University of California, Davis
Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation	NCT01741064	Secondary Hyper... Disorder Relate...		18 Years - 85 Years	Skane University Hospital
CD34 Selection Using the Automated CliniMACS Prodigy	NCT06047886	AML ALL Lymphoid Malign... Myelodysplastic... CML Primary Myelofi...	Infusion of CD3...	4 Weeks - 75 Years	University of Alabama at Birmingham

Spots Global Cancer Trial Database for graft failure