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therapeutic autologous dendritic cells

Phase 1

Melanoma (Skin) | Monoclonal antibody | Oncology |Lisata Therapeutics, Inc.|Last Updated: Jan 29, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

therapeutic autologous dendritic cells · 1 trial · 1 indication

Phase 1 1
NCT00012064Vaccine Therapy in Treating Patients With Stage IV or Recurrent MelanomaMelanoma (Skin)
COMPLETED56 Analytics
PHASE1COMPLETED
Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
Melanoma (Skin)Unlock trial analytics

Study Endpoints

Primary Endpoints

To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF
treatment
To determine the frequency of conversion of delayed tumor hypersensitivity (DTH) tests with irradiated autologous tumor cells, in patients who received an autologous dendritic cell/tumor cell vaccine with GMCSF
treatment

Secondary Endpoints

To determine the objective tumor response rate in patients with metastatic melanoma who still had measurable disease at the time vaccine treatment was given
follow-up
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Biological/VaccineEXPERIMENTALBiological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.

Interventions

NameTypeDescription
therapeutic autologous dendritic cellsBIOLOGICALApheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV or recurrent melanoma * Metastatic disease confirmed by MRI or CT scan * Planned resection of tumor * No active CNS metastases * Radiographically confirmed lack of CNS disease progression * No requirement for pharmacologic doses o...

Countries:United States
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Frequently asked questions about therapeutic autologous dendritic cells

What is therapeutic autologous dendritic cells used for?

Therapeutic autologous dendritic cells is an investigational cell-based vaccine being studied for the treatment of melanoma, specifically in patients with stage IV or recurrent melanoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who is developing therapeutic autologous dendritic cells?

Therapeutic autologous dendritic cells is being developed by Lisata Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol LSTA. The company is conducting clinical research to evaluate this investigational therapy for melanoma.

What phase is therapeutic autologous dendritic cells in?

Therapeutic autologous dendritic cells is in Phase 1 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under evaluation for safety and efficacy.

What clinical trials is therapeutic autologous dendritic cells in?

Therapeutic autologous dendritic cells has been studied in one completed Phase 1 clinical trial, identified as NCT00012064, titled "Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma." This trial enrolled 56 participants in the United States and was not randomized or blinded.

Is therapeutic autologous dendritic cells the same as a vaccine?

Therapeutic autologous dendritic cells is a type of vaccine therapy, as indicated by the clinical trial title. It is designed to treat melanoma by using the patient's own dendritic cells, which are modified and administered to stimulate an immune response against cancer cells.