Side Effects of 4 Times Bone Marrow Mono Nuclear Transplantation in Patients With Ischemic Lower Limb
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 4times injection the patients with ischemic lower limb ulcer who underwent 4times stem cell injection. |
Biological: 4times injection
bone marrow derived mono nuclear stem cell
|
| Experimental: one injection Patients with peripheral artery disease underwent cell transplantation just one time. |
Biological: stem cell transplantation
Mono nuclear stem cell transplantation by intra muscular injection to the ischemic lower limb
|
Outcome Measures
Primary Outcome Measures
- side effects [3months]
evaluation the side effect of cell injection like:allergic reaction,fever,skin eruption,pain increasing,decrease in walking distance,ulcer severity
Secondary Outcome Measures
- PFWD [3months]
Evaluation the pain free walking distance after cell transplantation.
- ABI [3months]
evaluation the improvement the score of ABI after stem cell transplantation .
- size and depth of ulcer [3months]
evaluation the improvement of ulcer by measuring the size and depth of ulcer in millimeter after transplantation.
- Amputation [6months]
Evaluation the need of limb amputation because of worsening the ulcer after cell injection.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royan Institute | Tehran | Iran, Islamic Republic of |
Sponsors and Collaborators
- Royan Institute
Investigators
- Study Chair: Hamid Gourabi, PhD, Head of Royan Institute
- Study Director: mohammad zafarghandi, MD, surgery scientist
- Study Director: Nasser Aghdami, MD,PhD, head of Royan cell therapy center
- Principal Investigator: Behnam Molavi, MD, Surgery scientist
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Royan-PVD-002