Side Effects of 4 Times Bone Marrow Mono Nuclear Transplantation in Patients With Ischemic Lower Limb

Ischemic Ulcer Clinical Trial

Official title:

Evaluation the Side Effects of Repeated Bone Marrow Derived Mono Nuclear Stem Cells Transplantation in Patients With Lower Limb Ischemic Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480414
• Other study ID #: Royan-PVD-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 23, 2011
• Last updated: December 25, 2012
• Start date: September 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic needs of the tissue, even under resting conditions. The limits of peripheral artery disease (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the pathophysiology of vascular disease. By stimulating these processes the investigators might be able to provide an alternative treatment strategy for patients with lower limb ischemia. In response to tissue injury and remodeling, neovascularization usually occurs via the proliferation and migration of progenitor endothelial cells (EPC) from preexisting vasculature. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC) implantation increases collateral vessel formation in patients with limb ischemia. So the investigators determine to evaluate the efficacy of repeated MNC transplantation in patients with ischemic lower limb.

Description:

In this study we transparent bone marrow derived mononuclear stem cells 4 times to the ischemic limb of 11 patients with PAD.first of all all the patients evaluate by physical examination,PFWD,ABI and serologic tests.then underwent bone marrow aspiration to take sample.In our lab the MNC are separated and divided in to equal doses.one of them inject to the ischemic foot and the othr one are freezed and inject after 3weeks.3 weeks after second injection again patient underwent bone marrow aspiration and the same process repeat.then after 4times transplantation,patients are followed up after 1,3,6,9,12 months after injection and evaluate by physical examination,PFWD,ABI and serologic tests.all the data are collected and analysed and the result will be shown.3 patients underwent cell transplantation just one time due to one time bone marrow aspiration.They are followed up after 1,3,6,9,12 months after injection and evaluate by physical examination,PFWD,ABI and serologic tests.at the end of the study patients with 4imes injection and 1time injection will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 62 Years

Eligibility

Inclusion Criteria:

• Ischemic lower limb based on TASK guide line

• Rutherford score:2,3

• ABI<0.6

• Absolute ankle pressure < 60 mmHg

• Both gender

• Age:20-62years

Exclusion Criteria:

• EF<30%

• Cr>2

• HbA1c>8%

• Bone marrow disorders:leukemia

• Cognitive disorders

• Infections

• MI with ST elevation during last month

• Malignancy

• Immunologic or rheumatologic disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Ulcer

Intervention

Biological:
• 4times injection
bone marrow derived mono nuclear stem cell
• stem cell transplantation
Mono nuclear stem cell transplantation by intra muscular injection to the ischemic lower limb

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	side effects	evaluation the side effect of cell injection like:allergic reaction,fever,skin eruption,pain increasing,decrease in walking distance,ulcer severity	3months	Yes
Secondary	PFWD	Evaluation the pain free walking distance after cell transplantation.	3months	No
Secondary	ABI	evaluation the improvement the score of ABI after stem cell transplantation .	3months	Yes
Secondary	size and depth of ulcer	evaluation the improvement of ulcer by measuring the size and depth of ulcer in millimeter after transplantation.	3months	Yes
Secondary	Amputation	Evaluation the need of limb amputation because of worsening the ulcer after cell injection.	6months	No