Safety and Feasibility of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-12-31

Brief Summary

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Recent researches indicate that impairment of vascular and endothelial homeostasis plays a major role in the initiation and development of IPAH.We have recently reported the safety and feasibility data for autologous endothelial progenitor cells (EPCs) injection in patients with IPAH. Yet many questions remain unanswered: what is the ideal quantity of EPCs for therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such therapy. To help answer these questions, we designed the one year follow-up to investigate the safety and efficacy of autologous EPCs injection in patients with IPAH.

Detailed Description

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Conditions

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Idiopathic Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Transplantation of autologous endothelial progenitor cells

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* A resting mean pulmonary-artery pressure greater than 30 mm Hg
* A pulmonarycapillary wedge pressure of less than 15 mm Hg
* Pulmonary vascular resistance greater than 240 dyn•sec•cm-5
* 18-60 years old

Exclusion Criteria

* Pulmonary disease
* Sleep-associated disorders
* Chronic thromboembolic disease
* Autoimmune or collagen vascular disease
* HIV infection
* Liver disease
* New York Heart Association functional class IV
* Major bleeding requiring blood transfusion
* Diabetes
* Renal dysfunction
* Evidence for malignant diseases were excluded

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Junzhu Chen, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

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Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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Wang XX, Zhang FR, Shang YP, Zhu JH, Xie XD, Tao QM, Zhu JH, Chen JZ. Transplantation of autologous endothelial progenitor cells may be beneficial in patients with idiopathic pulmonary arterial hypertension: a pilot randomized controlled trial. J Am Coll Cardiol. 2007 Apr 10;49(14):1566-71. doi: 10.1016/j.jacc.2006.12.037. Epub 2007 Mar 27.

Reference Type RESULT

PMID: 17418297 (View on PubMed)

Other Identifiers

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IPAH-EPC-2

Identifier Type: -

Identifier Source: org_study_id