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Autologous bone marrow derived mononuclear cells (BMMNCs) subfacial transplantation in idiopathic lymphedema patients: clinical trial phase I

Protocol summary

Summary
Objectives: safety assessments of subfacial transplantation of autologous bone marrow derived mononuclear cells (BMMNCs) in idiopathic lymphedema patients. Design: A Phase I, Multicenter, Un-Controlled, Non-Randomized, Open label Clinical Trial. Methods: 6 patients with Idiopathic lower limb lymphedema; age between 10-35 years; Grade less than III; Resistant to conventional therapy and both gender selected . They underwent bone marrow aspiration. The prepared autologous bone marrow derived mononuclear cells inject subfascially during lymph pathway in involved leg. They follow at 1,2,3,6 and 12 months after transplantation by clinical assessments Questionnaire, Water displacement leg volumetry and circumference measurement. The primary endpoint was assessed by clinical assessment of safety including redness, swelling, itching, inflammation, infection, reduced sensitivity and etc.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201611241031N19
Registration date: 2017-01-27, 1395/11/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-27, 1395/11/08
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR.
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Autologous bone marrow derived mononuclear cells (BMMNCs) subfacial transplantation in idiopathic lymphedema patients: clinical trial phase I
Public title
Autologous bone marrow derived mononuclear cells transplantation in idiopathic lower limb lymphedema patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 10-35 years; Idiopathic lower limb lymphedema; Grade less than III ; Resistant to conventional therapy; Informed consent. Exclusion criteria: Heart Failure (EF less than 45%); Renal failure (Cr more than 2) ; Hepatic failure (LFT more than 3 times) ; History of related surgery (lymph node dissection); History of Autoimmune disease; History of trauma or infection; History of pelvic malignancy or treatment for malignancy (Irradiation); Symptoms of sleep apnea; Previous bone marrow transplant; Morbid obesity or Lipedema (BMI ≥ 40); Allergic disorders; Cytotoxic drugs; Drugs induced lymphedema; Congenital vascular malformation; Myxedema; Traveling to tropical countries or suspicion to filariasis; Dependency.
Age
From 10 years old to 35 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 6
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
not used

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethic and Law Research Center, Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran Highway
City
Tehran
Postal code
1985717443
Approval date
2014-02-09, 1392/11/20
Ethics committee reference number
SBMU.REC.1392.656

Health conditions studied

1

Description of health condition studied
Idiopathic lower limb lymphedema
ICD-10 code
I89.9
ICD-10 code description
Noninfective disorder of lymphatic vessels and lymph nodes, unspecified

Primary outcomes

1

Description
Safety
Timepoint
Base, 1,2,3,6 and 12 months after transplantation
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Edema volume
Timepoint
base, 1,2,3,6 and 12 months after transplantation
Method of measurement
Water displacement leg volumetry, Circumference measurement

2

Description
SF-36 Health Status Questionnaire
Timepoint
6 and 12 months after transplantation
Method of measurement
Questionnaire

Intervention groups

1

Description
Sub-facial transplantation of autologous bone marrow drived mononuclear cell. 0.5-1 cc per point injection. number of point injection is one third of leg length plus 1. cell suspension is half of number of point injections in involved leg
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada e Tajrish Hospital
Full name of responsible person
Dr. Seyed Reza Moosavi
Street address
Tajrish Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Hamid Gourabi
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Aliasghar Peyvandi
Street address
Shahid Beheshti University of Medical Science, Velenjak St. Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Science
Proportion provided by this source
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
Royan Institute
Full name of responsible person
Hoda Madani
Position
M.D/Researcher
Other areas of specialty/work
Street address
Eastern Hafez St, Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2356 2458
Fax
Email
hoda62_m@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Nasser Aghdami
Position
M.D/Ph.D
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2356 2000
Fax
Email
nasser.aghdami@royaninstitute.org
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Hoda Madani
Position
Researcher/M.D
Other areas of specialty/work
Street address
Royan Institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
00
Fax
Email
hoda62_m@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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