Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201709002519185 Date of Approval: 14/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of adipose derived stem cells in management of chronic ulcers: clinical and laboratory study
Official scientific title Efficacy of adipose derived stem cells in management of chronic ulcers: clinical and laboratory study
Brief summary describing the background and objectives of the trial Wound healing is an elaborate process that occurs in distinct, yet overlapping phases of well orchestrated cascade of biological and molecular processes: hemostasis, inflammation, proliferation and remodeling. Chronic wounds occur when there is failure of injured skin to proceed through an orderly and timely process to produce anatomic and functional integrity. Despite of the huge advances in medical care, chronic non-healing wounds still represent a challenge in our practice. New therapies are required to optimize wound healing like cell therapies. Cell therapy is defined as a set of strategies to use living cells as a regenerative therapy to repair, replace or restore biological function. The term stem cells refers to a myriad of different cell types that share two key characteristics: Self-renewal and the potential for differentiation into different cell types and they are pleuripotent cells. In 2001, Zuk et al. demonstrated that human fat obtained from human lipoaspirates contained multilineage stem cells, which have since been shown to have the potential to undergo adipogenesis, osteogenesis, chondrogenesis and myogenesis in vitro and in vivo. Stem cells enhance cutaneous wound healing through trophic and paracrine activity. The aim of using stem cells in wound healing is to increase the rates of healing whilst improving the quality of healing resulting in more of regenerative process rather than a repairing one.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Chronic ulcers,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/09/2017
Actual trial start date 06/09/2017
Anticipated date of last follow up 06/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using by using coin-tossing Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Injection of stem cells derived from fat tissue 3 times 2 weeks apart injection of stem cells suspension derived from adipose derived stem cells 50
Control Group Conventional dressing methods Every other day 6 weeks Dressing by antiseptics and healing promoting ointments 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age: 15-55 years old. 2. Chronic non-healing ulcer... Diabetic and trophic ulcers 1. Age less than 15 or older than 55 years old. 2. Immunocompromised patients. 3. Cancer patients. 4. Mental patients. 15 Year(s) 55 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 27/08/2017 Ethics committee of Faculty of Medicine, Assiut University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Assiut University Assiut 17777 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evaluation the efficacy of ASCs therapy in treatment of non-healing ulcers After 6 weeks
Secondary Outcome Diameter of ulcer 6 weeks
Secondary Outcome State of floof of ulcer 6 weeks
Secondary Outcome Amount of stem cells needed 6 weeks
Secondary Outcome Histological findings 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut University Hospital University st. Assiut 17777 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Assiut University Hospital University st. Assiut 17777 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Upper Egypt Cancer Institute Ma'had El-Awram St. Assiut 17777 Egypt Hospital
Primary Sponsor Assiut University Hospital University st. Assiut 17777 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Youssef Saleh Assiut University Hospital Assiut 17777 Egypt
Dr. Ahmed Kamal Assiut University Hospital Assiut 17777 Egypt
Dr. Noha Gaber Upper Egypt Cancer Institute Assiut 17777 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emil Tanios myelo_21st@yahoo.com +201226736855 4th Farouk Kedwany St.
City Postal code Country Position/Affiliation
Assiut 17777 Egypt Specialist of plastic surgery
Role Name Email Phone Street address
Public Enquiries Youssef Saleh plasticclinic66@gmail.com 01001166118 Assiut University Hospital
City Postal code Country Position/Affiliation
Assiut 17777 Egypt Head of plastic surgery department
Role Name Email Phone Street address
Scientific Enquiries Ahmed Kamal ahmedkamal@aun.edu.eg +2010600118001 Assiut University Hospital
City Postal code Country Position/Affiliation
Assiut 17777 Egypt Assistant professor of plastic surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information