Cenplacel-L (Celularity)(Cenplacel-L (Celularity))

概要

基本信息

药物类型

干细胞疗法

别名

Cenplacel、PDAC cells - Celgene Cellular Therapeutics

靶点-

作用机制

细胞替代物

治疗领域

免疫系统疾病神经系统疾病心血管疾病+ [2]

在研适应症-

非在研适应症

克罗恩病大脑中动脉梗塞大脑后动脉梗塞+ [3]

原研机构

Celgene Cellular Therapeutics

在研机构-

非在研机构

Celgene Corp.Celgene Cellular Therapeutics

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

5

项与 Cenplacel-L (Celularity) 相关的临床试验

NCT01769755 / Completed临床1期

A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease

To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohn's disease who are refractory to one or more standard Crohn's disease therapies.

开始日期2013-03-01

申办/合作机构

Celularity, Inc.

NCT01440192 / Terminated临床1期

A Phase 1B, Multi-Center, Open-Label, Single Dose Study to Evaluate the Safety of Intravenous Infusion of Human Placental-Derived Cells (PDA001) for the Treatment of Adults With Stage II or III Pulmonary Sarcoidosis.Sarcoidosis

The primary objective of the study is to assess the safety and tolerability of a single dose of PDA001 (given twice) in subjects with Stage II or III Pulmonary Sarcoidosis (PS) who are refractory to one or more of the following treatments for PS: methotrexate,immunosuppressants or cytotoxic agents.

开始日期2011-09-01

申办/合作机构

Celularity, Inc.

NCT01310114 / Terminated临床2期

A Phase 2A, Prospective, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults Following Ischemic Stroke

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.

开始日期2011-03-01

申办/合作机构

Celularity, Inc.

[+1]

100 项与 Cenplacel-L (Celularity) 相关的临床结果

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100 项与 Cenplacel-L (Celularity) 相关的转化医学

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100 项与 Cenplacel-L (Celularity) 相关的专利（医药）

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11

项与 Cenplacel-L (Celularity) 相关的文献（医药）

2021-09-01·Journal of the Peripheral Nervous System3区 · 医学

Phase 2a randomized controlled study investigating the safety and efficacy of PDA‐002 in diabetic peripheral neuropathy

3区 · 医学

Article

作者: Hariri, Robert ; Veves, Aristidis ; Habboubi, Nassir ; Zhang, Xiaokui ; Gibbons, Christopher H. ; Zhu, Junhong

AbstractNeuropathy is a major cause of morbidity and mortality in individuals with diabetes, with no effective therapy to alter the inevitable progression of nerve damage. We hypothesized that mesenchymal stroma cell‐like populations, that are characterized as immune modulators also have the potential of inducing angiogenesis and neurite outgrowth, might be useful in treating diabetic peripheral neuropathy (DPN). The aims of this study were to investigate the efficacy and safety of mesenchymal stem cell‐like product (PDA‐002) in treating DPN. A phase‐2 randomized placebo‐controlled trial was conducted in 26 patients with DPN. Treatment consisted of three rounds of intramuscular injections in one lower limb using one of the three randomized treatment arms PDA‐002 (low‐dose 3 × 106 cells), PDA‐002 (high‐dose 30 × 106 cells), or placebo. Three treatments per patient occurred on days 1, 29, and 57. Study endpoints included efficacy and safety of PDA‐002 in treating DPN in both lower extremities following unilateral local injection. Outcome measures included intra‐epidermal nerve fiber density (IENFD) up to 1 year from the day of treatment with 6‐month as the primary outcome measurement. In this phase 2 study of DPN, PDA‐002 was well tolerated in both doses. No significant changes were noted in IENFD in both the treated and untreated leg in the NIS‐LL, NTSS‐6, or UENS. Mesenchymal stem cells represent a novel mechanism for treating diabetic neuropathy and are well tolerated. Preliminary results highlight the need of further investigation of PDA‐001 as a disease modifying agent for treatment of DPN.

2017-10-01·International Wound Journal3区 · 医学

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

3区 · 医学

Article

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

AbstractThe 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.

2015-08-01·Inflammatory Bowel Diseases2区 · 医学

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

2区 · 医学

Article

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

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

100 项与 Cenplacel-L (Celularity) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
大脑中动脉梗塞	临床2期	美国	Celgene Corp.	2011-03-01
大脑后动脉梗塞	临床2期	美国	Celgene Corp.	2011-03-01
类风湿关节炎	临床2期	美国	Celgene Corp.	2010-12-01
克罗恩病	临床2期	美国	Celgene Corp.	2010-08-01
神经痛	临床2期	美国	Celgene Cellular Therapeutics	-
缺血性卒中	临床前	美国	Celgene Corp.	2011-03-01