There are no Effective Therapeutic Interventions for Lymphatic Vessels Disease. The efficacy of some Methods like Physical Combined Therapy Demands more time and money with lower Effectiveness. Inclusion Criteria are Congenital Atresia or Hypoplasia of Lymphatic Vessels and Exclusion Criteria are any Inflammatory or Malignant Disease. Research Study is carried out on 5 Samples from Human Population. It seems Injection of Stem Cells in Edema Region can Stimulate Cytokine Excretion and Finally Improve Function of Endothelial Cells of Lymphatic Vessels or making new Lymphatic Systems. For every Patient Recombinant Granulocyte Colony-Stimulating Factor (5 Microgram per Kilogram of Body Weight) is Injected Subcutaneously for 5 days long. At this period, Stem Cells (Endothelial Precursors) are Recruited from Bone Marrow to Peripheral Blood. Daily White Cell Count is done until we reach Desirable Mononuclear Count and then they will be Collected from Peripheral Blood. Then this Solution which contains Mononuclear Cells, will be Concentrated and Final Volume of Solution will be 120 cc. this Solution will be then Injected in Sterile Method in Anatomic Pathway of Lymphatic Vessels of Lower Limb, from left Groin to Distal part of left Shinbone. Percentage of CD34+/CD133+ Cells will be measured before Injection by flow Cytometry Method. Several Tests will be done on Patient after Injection of Autolog Stem Cells, to Assay Clinical and Lymphoscintigraphy Findings. These Parameters will be Compared to data before Intervention. 40 days after Stem Cells Injection, Probably Diameter of lower Limb will be Reduced Significantly in Comparison to Pre Intervention Diameter.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202209083N1
Registration date:2012-03-12, 1390/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-12, 1390/12/22
Registrant information
Name
Habiballah Peirovi
Name of organization / entity
nanomedicine&tissue engineering research center- shahid behesht medical university
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9848
Email address
dhpsurgery@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences, Stem Cell
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Autologous Adult Stem Cell Induced-Lymphangiogenesis in Peripheral Lymphedema
Public title
Autologous Adult Stem Cell Induced-Lymphangiogenesis in Peripheral Lymphedema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:/ Congential Atresia or Hypoplasia of Lymphatic Vesseles
Exclusion Criteria :/Inflamatory Malignant Disease
Age
From 16 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti of Medical University
Street address
Nano, Taleghani Hospital, Velenjak, Shahid Beheshti of Medical University
City
Tehran
Postal code
198571-7413
Approval date
2012-01-29, 1390/11/09
Ethics committee reference number
112
Health conditions studied
1
Description of health condition studied
Lymphoedema
ICD-10 code
I89.0
ICD-10 code description
Lymphoedema, not elsewhere classified
Primary outcomes
1
Description
Diametr of Organ
Timepoint
15 day, 1 m, 3m, 6m, 12m
Method of measurement
Centimeter
2
Description
Lymphosentigraphy
Timepoint
15 day, 1 m, 3m, 6m, 12m
Method of measurement
Lymphosentigraphy
Secondary outcomes
empty
Intervention groups
1
Description
1) Bone Marrow Aspiration
2) Detachment Precursur Cell Endothelial with CLINIMACS Cell Sُُeparator System
3) Cell Culture
4) Injection Subcutanens in Local Specific
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital,
Full name of responsible person
Dr Habib Allah Peirovi
Street address
Taleghani Hospital, Velenjak,
City
Thran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Staff of Stemcell ,By Shahid Beheshti of Medical University
Full name of responsible person
Dr Mohammad Vaseii
Street address
Room 304, Floor 3, Adjutancy of Research Department, Avesta Park, Aazadi
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Staff of Stemcell ,By Shahid Beheshti of Medical University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nano Medicine& Tissue Engineering Research Center (Shahid Beheshti of Medical University)
Full name of responsible person
Dr Habib Allah Peirovi
Position
Proff of General & Vascular Surgery( Head of Center )
Other areas of specialty/work
Street address
Nano Medicine& Tissue Engineering Research Center (Shahid Beheshti of Medical University)