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Investigating the Effects of Peripheral Blood Stem Cells Injection in Treatment of Primary Lower Extremity Lymphedema

Protocol summary

Study aim
The aim of this pilot before and after single arm clinical trial is the cure of lymphedema via induction of lymphangiogenesis by autologous peripheral blood stem cells injection to the unilateral lymphedematous lower extremity. To reach this goal, improvements will be tracked histopathologically (average number of lymphatic vessels via biopsy), by imaging (lymphoscintigraphy), clinically (stage of lymphedema and measurement of circumference and volume of the limb) and via patients' sense of wellness (quality of life). The other goals are assessment the relation between these variables and the age, duration and severity of disease.
Design
A pilot before and after single arm clinical trial with a single group of 10 patients
Settings and conduct
This study will be totally taking place in Shariati Hospital of the Tehran University of Medical Science, Tehran, Iran. The recruitment and follow up center is the hospital's vascular surgery clinic, the cell preparations will be proceeded in the hospital's Hematology, Oncology and Stem Cell Transplantation Research Center and the stem cells will be injected in the hospital's operation room. The experts of the hospital's pathology lab and nuclear medicine imaging center will do the histopathologic investigation and lymphoscintigraphy. The main investigators may be keep blinded from the primary histopathologic and lymphoscintigraphic data (except the presence of lymphedema).
Participants/Inclusion and exclusion criteria
Patients with lower extremity/ies primary lymphedema will be recruited and among them, patients with history of malignancy or radio/chemotherapy or organ transplantation in the last 10 years and coronary artery disease, severe heart failure (EF<30%), chronic renal disease, diabetes and uncontrolled hypertension and active infection in the lower extremity will be excluded.
Intervention groups
The intervention is including 3-5 days of subcutaneously injection of GCSF for stem cell recruitment from bone marrow into the peripheral blood and then drawing blood from peripheral vessels to separate the peripheral blood stem cells. After cell preparations, half of the cells will be injected subcutaneously into the unilateral lymphedematous lower limb in about 80 points and the other half of the cells will be frozen for the similar injection 3 weeks later. Also, a punch biology for histopathologic investigation and lymphoscintigraphy will be obtained before the intervention and at the end of the 9 months of follow up. Patients will fill the Quality of Life questionnaire before the intervention and after the 9 months of follow up. The essential variable is the circumference and volume of the limb which will be measured monthly for 9 months.
Main outcome variables
Circumference and volume of the lower extremity, lymphoscintigraphic transport index, average number of subcutaneous lymphatic vessels and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171023036966N1
Registration date: 2018-01-22, 1396/11/02
Registration timing: registered_while_recruiting

Last update: 2018-01-22, 1396/11/02
Update count: 0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Vida Ehyaee Ghodraty
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6443 2592
Email address
v-ehyaeegh@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-19, 1396/10/29
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effects of Peripheral Blood Stem Cells Injection in Treatment of Primary Lower Extremity Lymphedema
Public title
Using the Stem Cells to Cure Lower Limb Lymphedema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
primary lower extremities lymphedema (stage < III)
Exclusion criteria:
Uncontrolled hypertension Diabetes Sever heart failure (EF<30 %) Coronary arterial disease Chronic renal disease History of any malignancies over the last 10 years History of chemo/radiotherapy in the last 10 years Organ transplantations in the last 10 years Active infection of the lower extremities
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
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
Research Ethics committee of Tehran University of Medical Science
Street address
Office #605, 6th floor, core building of Tehran University of Medical Science, cross section of Ghods street and Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2984

Health conditions studied

1

Description of health condition studied
Lymphedema is the accumulation of lymphatic fluid in the extravascular space resulted from dysfunction of lymphatic drainage because of mostly structural damage in lymphatic vessels. Various etiology of lymphedema is consist of primary and genetic malfunctions presenting the disease congenitally, over the first year after birth, up to 35 years or after this age and cancers and their treatment methods, traumas and other causes for example filariasis can cause the secondary lymphedema which is more common. Once lymphedema occurs it may be progressive with different rates and transform the involving limb and this causes pain, movement limitations and makes the limb prone to infections. There are various methods of management but not curative like compression therapies and surgical methods.
ICD-10 code
I89.0
ICD-10 code description
Lymphedema, not elsewhere classified

2

Description of health condition studied
Hereditary lymphedema is the primary lymphedema in which genetically malfunctional lymphatic vessels rather than obstructions or destructions via cancer, trauma and etc. lead to lymphatic drainage dysfunction and lymph-edema.
ICD-10 code
Q82.0
ICD-10 code description
Hereditary lymphedema

Primary outcomes

1

Description
Circumference of the lymphedematous lower extremity in specific distances of the limb length
Timepoint
Before intervention and then monthly up to 9 months
Method of measurement
Tape measuring

2

Description
Volume of the Circumference of the lymphedematous lower extremity
Timepoint
Before intervention and then monthly up to 9 months
Method of measurement
Volume of truncated cone formula

Secondary outcomes

1

Description
Quality of life
Timepoint
Before intervention and end of the follow up time (9 months after intervention)
Method of measurement
WHO QOL questionnaire (SF 26)

2

Description
Lymphoscintigraphic Transport Index (TI)
Timepoint
Before intervention and end of the follow up time (9 months after intervention)
Method of measurement
Report of lymphoscintigraphy by the expert nuclear medicine specialist

3

Description
Average number of subcutaneous lymphatic vessels of the lower extremities
Timepoint
Before intervention and end of the follow up time (9 months after intervention)
Method of measurement
Histopathologic investigation and immunohistochemistery (IHC) staining by the expert pathologist

Intervention groups

1

Description
Intervention group: a single group of 10 patients with primary lower extremity(ies) lymphedema, with no exclusion criteria, will receive 10mcg/kg/day of G-CSF for 3-5 days to recruit more stem cells from bone marrow to peripheral blood. Stem cells will be separated from 200-300 cc of peripheral blood drawn from the cubital vein. Half of the cells will be injected subcutaneously to 80-100 points of unilateral limb and the other half will be frozen for a second injection, 3 weeks later. The circumference and volume of the limb (monthly), the average number of lymphatic vessels (via biopsy), severity of lymphedema (lymphoscintigraphy and transport index), and the quality of life (questionnaire) will be compared before and after the 9 months past the intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Vascular Surgery in Shariati Hospital
Full name of responsible person
Behnam Molavi
Street address
North Kargar street, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2227
Fax
+98 21 8863 3039
Email
molavibe@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hematology,Oncology and Stem Cell Transplantation Research Center
Full name of responsible person
Saeed Mohammadi
Street address
North Kargar street, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
saeed_58@yahoo.com
Web page address
http://horcsct.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology,Oncology and Stem Cell Transplantation Research Center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Vascular Surgery, Shariati Hospital
Full name of responsible person
Behnam Molavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular and Endovascular surgery
Street address
North kargar street, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2227
Fax
+98 21 8863 3039
Email
molavibe@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Vascular Surgery, Shariati Hospital
Full name of responsible person
Behnam Molavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular and Endovascular Surgery
Street address
North Kargar street, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
14111713135
Phone
+98 21 8490 2227
Fax
+98 21 8863 3039
Email
molavibe@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shariati Hospital
Full name of responsible person
Vida Ehyaee Ghodraty
Position
Physician in practice
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
North Kargar street, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2304
Email
vdehyaee@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the deidentified measurements from the participants including medical history and data of size of the limb, lymphoscintigraphic and histhopathologic procedures and data before and after the intervention and also the detailed cellular preparations procedures will be available for other researchers.
When the data will become available and for how long
It can become available just after finding a dramatic result or at the end of the study for an unlimited time.
To whom data/document is available
All the information will be available for research ethic committees, detailed procedures and statistics can be available for researchers and the results and summary of procedures can be useful for industries and lymphedematous patients.
Under which criteria data/document could be used
Not specific criteria.
From where data/document is obtainable
During the study, please contact the project e-mail: lymphedema.research.tums@gmail.com After publishing the article there will be a guide for obtaining it.
What processes are involved for a request to access data/document
Contact with project email and send your request. lymphedema.research.tums@gmail.com
Comments
lymphedema.research.tums@gmail.com
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