Allocetra

Overview

Allocetra is a novel therapy where billions of early apoptotic cells are infused into the bloodstream of a patient, using the body's own natural regulation mechanisms to rebalance an unbalanced immune system without immune system suppression. With infusion, the body's macrophages and dendritic cells can feed on these early apoptotic Allocetra cells and thus result in the macrophages and dendritic cells releasing fewer cytokine alert signals so that the immune system is rebalanced back to normal -- averting a cytokine storm. This drug is currently being investigated against organ failure associated with sepsis, organ failure associated with COVID-19, post-bone marrow transplantation complications, and solid tumors.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ)	2024/12/27	NCT06748651	Phase 1	Recruiting	Dr. Amit Druyan
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis	2024/07/26	NCT06522035	Phase 1	Recruiting	Enlivex Therapeutics Ltd.
Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint	2024/06/14	NCT06459063	Phase 1	Recruiting	Kaplan Medical Center
Study of Intra-articular Allocetra in Knee Osteoarthritis	2024/01/31	NCT06233474	Phase 1	Active, not recruiting	Enlivex Therapeutics Ltd.
Use of Allocetra-OTS in End Stage Knee Osteoarthritis - Assessment of Safety	2024/01/17	NCT06208241	Early Phase 1	Active, not recruiting	Amir Oron
A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy	2022/10/14	NCT05581719	Phase 1	Terminated	Enlivex Therapeutics RDO Ltd.
Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis	2022/06/24	NCT05431907	Phase 1	Terminated	Enlivex Therapeutics RDO Ltd.
A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS)	2021/06/11	NCT04922957	Phase 2	Terminated	Enlivex Therapeutics Ltd.
Study Evaluating Safety and Tolerability of Allocetra-OTS in Patients With COVID-19	2020/12/09	NCT04659304	Phase 1	UNKNOWN	Enlivex Therapeutics Ltd.
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients	2020/11/03	NCT04612413	Phase 2	Completed	Enlivex Therapeutics Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Enlivex Reports Promising Results in Phase I/II Trial of Allocetra for Severe Knee Osteoarthritis

7 months ago

• Initial data from Enlivex's Phase I/II trial shows Allocetra treatment resulted in 64% average pain reduction in patients with severe knee osteoarthritis who were candidates for knee replacement surgery. • One-third of treated patients experienced complete pain resolution, with pain scores dropping from an average of 9 to 0, demonstrating significant therapeutic potential. • The treatment demonstrated a favorable safety profile in this high-need patient population, marking a potential breakthrough for end-stage osteoarthritis management.

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