Delving into the Latest Updates on Cenplacel-L (Celularity) with Synapse

Overview

Basic Info

Drug Type

Stem cell therapy

Synonyms

Cenplacel, PDAC cells - Celgene Cellular Therapeutics, PDA-001

Target-

Action-

Mechanism

Cell replacements

Therapeutic Areas

Immune System DiseasesNervous System DiseasesCardiovascular Diseases+ [3]

Active Indication

Crohn DiseaseDiabetic foot ulcer

Inactive Indication

Infarction, Middle Cerebral ArteryInfarction, Posterior Cerebral ArteryIschemic stroke+ [2]

Originator Organization

Celgene Cellular Therapeutics

Active Organization

Celularity, Inc.

Inactive Organization

Celgene Corp.Celgene Cellular Therapeutics

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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The primary objective of the study is to assess the safety and tolerability of Human Placenta-Derived Cells (PDA001) at 3 different dose levels versus placebo (vehicle control) administered intravenously in subjects following ischemic stroke. The secondary objective of the study is to assess the effect of PDA001 on improvement in clinical function following ischemic stroke.

Start Date01 Mar 2011

Sponsor / Collaborator

Celularity, Inc.

[+1]

100 Clinical Results associated with Cenplacel-L (Celularity)

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100 Translational Medicine associated with Cenplacel-L (Celularity)

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100 Patents (Medical) associated with Cenplacel-L (Celularity)

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10

Literatures (Medical) associated with Cenplacel-L (Celularity)

01 Oct 2017·International wound journalQ3 · MEDICINE

Safety and efficacy of intramuscular human placenta‐derived mesenchymal stromal‐like cells (cenplacel [PDA‐002]) in patients who have a diabetic foot ulcer with peripheral arterial disease

Q3 · MEDICINE

Article

Author: Robert G Frykberg ; Richard Pollak ; Stephanie C Wu ; Denesh Chitkara ; Vladimir Jankovic ; Maha Karnoub ; Wei Zhou ; Steven A Fischkoff

Abstract:

The objective of this study was to examine the safety of cenplacel (PDA‐002) in patients with peripheral arterial disease (PAD) and a diabetic foot ulcer (DFU). Cenplacel is a mesenchymal‐like cell population derived from full‐term human placenta. This phase 1, dose‐escalation study investigated cenplacel in diabetic patients with chronic DFUs (Wagner grade 1 or grade 2) and PAD [ankle‐brachial index (ABI) >0·5 and ≤0·9], enrolled sequentially into each of four dose cohorts (3 × 106, 10 × 106, 30 × 106 and 100 × 106 cells; administered intramuscularly on study days 1 and 8 in combination with standard of care). Overall, cenplacel was well tolerated in all 15 patients in the study. Before enrollment, nine patients had an ulcer for ≥6 months and 11 had an ABI of 0·7–0·85. No patient met dose‐limiting toxicity criteria and no treatment‐related serious adverse events were reported. There was preliminary evidence of ulcer healing in seven patients (five complete; two partial) within 3 months of cenplacel treatment, and circulating endothelial cell levels (a biomarker of vascular injury in PAD) were decreased within 1 month. Cenplacel was generally safe and well tolerated in patients with chronic DFUs and PAD. Outcomes from this study informed the doses, endpoints, biomarkers and patient population for an ongoing phase 2 trial.

01 Aug 2015·Inflammatory bowel diseasesQ2 · MEDICINE

Human Placenta-derived Cells (PDA-001) for the Treatment of Moderate-to-severe Crohnʼs Disease

Q2 · MEDICINE

Article

Author: Steven Fischkoff ; John Valentine ; Stephen Targan ; Gil Y. Melmed ; Bincy Abraham ; Bruce Sands ; William M. Pandak ; Kevin Casey ; Issac Bassan ; David Schwartz ; Stephen Hanauer ; Ioannis Oikonomou ; Nimisha Parekh ; Kristine Johnson ; Dahlia Awais ; Robert Richards ; Simon Lichtiger ; Robert Hariri

BACKGROUND:

PDA-001 (cenplacel-L), a preparation of placenta-derived mesenchymal-like adherent cells with immunomodulatory effects, previously demonstrated safety and tolerability in an open-label Crohn's disease (CD) study. The current phase 1b/2a study evaluated the safety and efficacy of PDA-001 in subjects with moderate-to-severe CD.

METHODS:

Subjects had active inflammation on colonoscopy or elevated fecal calprotectin and inadequate response to conventional therapy. Concomitant therapy with stable doses of immunomodulators and/or biologics was permitted. Subjects received 8 units of PDA-001 (1.5 × 10 cells per unit) in the phase 1b open-label study. In the phase 2a double-blind study, subjects were randomly assigned placebo, 1 unit, or 4 units of PDA-001 (2 infusions 1 wk apart). The primary endpoint was induction of clinical response (≥100 points and/or 25% decrease in Crohn's Disease Activity Index) at 4 and 6 weeks.

RESULTS:

Fifty subjects were enrolled (safety analysis, 50 subjects; efficacy analysis, 48 subjects). Four subjects received 8 units of PDA-001 (phase 1b study); 46 subjects were subsequently randomized to 1 or 4 units of PDA-001 or placebo (phase 2a study). The primary endpoint was achieved in 10/28 (36%) of PDA-001 subjects compared with placebo (0%, P = 0.026). Clinical remission was achieved in 4/28 (14%) of PDA-001 subjects compared with placebo (0%, P = 0.3). One treatment-related serious adverse event occurred (systemic hypersensitivity reaction at 8 units). In the phase 2a study, serious adverse events occurred in 9/28 (32%) of PDA-001 subjects and 1/16 (7%) of placebo subjects.

CONCLUSIONS:

A 2-infusion regimen of PDA-001 induced clinical response in subjects with moderate-to-severe CD. Additional studies are warranted.

22 Jul 2015·Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOGQ4 · MEDICINE

Placenta-derived mesenchymal-like cells (PDA-001) as therapy for chronic pulmonary sarcoidosis: a phase 1 study.

Q4 · MEDICINE

Article

Author: Fischkoff, Steven ; Lower, Elyse E ; Culver, Daniel A ; Jankovi, Vladimir ; Brockway, Giorgia ; Baughman, Robert P

BACKGROUND:

Placental derived mesenchymal-like cells have been found to have immunosuppressive effects on T cell function. We studied mesenchymal-like cells as immunomodulators in chronic pulmonary sarcoidosis.

METHODS:

PDA-001 cells were culture-expanded in vitro as a plastic-adherent, undifferentiated cell population that expresses the nominal phenotype CD34-, CD10+, CD105+ and CD200+. Four patients with refractory pulmonary sarcoidosis received two infusions of 150 million PDA-001 cells in 240 ml dextran-40 solution one week apart. During and for two hours after the first infusion, the pulmonary artery pressure was monitored. Prior to first infusion and within 24 hours after the second infusion, bronchoscopy and bronchoalveolar lavage (BAL) were performed. Patients underwent initial and serial pulmonary function testing and were followed for two years.

RESULTS:

After the first infusion, all patients had a mild, non-clinically significant increase in mean pulmonary artery pressure, but none exhibited right heart failure or volume overload. In the year following treatment, there was no significant change in the FVC, but two patients had improvement in their chest x-ray and had prednisone withdrawn. BAL samples after the second infusion were sufficiently viable to undergo FACS analysis in three cases and in two patients, CD10+CD49c+C105+ cells (indicative of PDA-001 cells) were found.

CONCLUSION:

The use of placental derived mesenchymal-like cells led to a mild increase in pulmonary artery pressure. In some cases, these cells were found in the BAL 24 hours after the second dose. Two of four patients demonstrated some steroid sparing benefit, including one patient with prolonged remission.

100 Deals associated with Cenplacel-L (Celularity)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Infarction, Middle Cerebral Artery	Phase 2	United States	Celgene Corp.	01 Mar 2011
Infarction, Posterior Cerebral Artery	Phase 2	United States	Celgene Corp.	01 Mar 2011
Ischemic stroke	Phase 2	United States	Celgene Corp.	01 Mar 2011
Rheumatoid Arthritis	Phase 2	United States	Celgene Corp.	01 Dec 2010
Crohn Disease	Phase 2	United States	Celgene Corp.	01 Aug 2010
Diabetic foot ulcer	Phase 2	United States	Celularity, Inc.	-
Neuralgia	Preclinical	United States	Celgene Cellular Therapeutics	-