Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications

This is an interventional treatment trial for Graft-Versus-Host Disease focused on measuring Immune Suppression, BMSC, GVHD, Marrow Failure, Regimen Related Toxicity, Graft-Versus-Host Disease Read More

• INCLUSION CRITERIA:

5.1.1 History of allogeneic SCT

Any subject who has received an allogeneic SCT at NIH is eligible if they have one or more of the following conditions. Subjects may continue to receive standard treatments for their condition but may not be entered onto a new investigational protocol to treat the condition during the period of evaluation of BMSC infusions.

5.1.1.1 Acute GVHD

Biopsy confirmed within 14 days of investigational intervention (unless not possible to perform because of anatomical location or clinical contraindication) acute GVHD affecting gut and/or liver and/or skin, defined as steroid refractory: failure to respond to greater than or equal to 2mg/kg methylprednisolone (or equivalent) after 7 days OR steroid dependent: requiring methylprednisolone (or equivalent) greater than or equal to 1mg/kg for greater than or equal to 7days for control of GVHD. GVHD affecting the skin alone is rarely lethal and is excluded. Acute GVHD is defined using the NIH consensus definition inclusive of Classic acute (< 100 days after transplant or DLI, presence of acute GVHD features, absence of chronic GVHD features) AND Persistent/recurrent/late onset acute (> 100 days after transplant or DLI, presence of acute GVHD features, absence of chronic GVHD features).

5.1.1.2 Marrow Failure

Poor graft function in the presence of >95% donor myeloid chimerism: defined as platelet or red cell transfusion dependent OR absolute neutrophil count persisting <500/ (Micro)l for 14 days without other reversible or treatable causes.

5.1.1.3 Pulmonary injury

Lung injury from: Diffuse alveolar hemorrhage (DAH), Cryptogenic Organizing Pneumonia (COP), Bronchiolitis Obliterans Syndrome (BOS), idiopathic interstitial pneumonia (IP), Adult respiratory distress syndrome (ARDS) diagnosed by exclusion of active infection. Also worsening pneumomediastinum or pneumothorax persisting after 7 days; at risk for causing hemodynamic changes in association with any of these diagnoses.

5.1.1.4 Hepatic injury

Clinically diagnosed sinusoidal obstruction syndrome (SOS), previously known as veno-occlusive disease (VOD), with bilirubin > 2 times ULN or transaminases >3 times ULN and rising.

5.1.1.5 Hemorrhagic cystitis (HC)

HC requiring continuous bladder irrigation OR requiring red cell or platelet transfusions at least intermittently for the past 7 days OR HC unresponsive to antivirals after 10 days.

5.1.1.6 Gastrointestinal tract

Pneumoperitoneum, bowel perforation not susceptible to corrective surgery OR blood transfusion requirement > 1 unit per day for 7 days.

5.1.2 Age: greater than or equal to 18 years of age and less than or equal to 75 years of age.

5.1.3 Birth Control

Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.

5.1.4 Transplant performed at NIH.

EXCLUSION CRITERIA:

5.2.1 Breast feeding or pregnant females (due to unknown risk to fetus or newborn).

5.2.2 Allergic to gentamicin

5.2.3 Weight less than 20 kg (not informative for research sampling)

5.2.4 Patients with significant organ failure at baseline as evidenced by any of the following:

1. <TAB>Symptomatic cardiac failure at rest or with minimal activity or exertion for which intervention is indicated
2. <TAB>Creatinine > 3.0 X ULN
3. <TAB>Decreased oxygen saturation at rest (e.g. pulse oximeter < 88% or PaO2 less than or equal to 55 mmHg)