Intramuscular Transplantation of Muscle Derived Stem Cell and Adipose Derived Mesenchymal Stem Cells in Patients With Facioscapulohumeral Dystrophy (FSHD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02208713|
Recruitment Status : Recruiting
First Posted : August 5, 2014
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dystrophy||Biological: Intramuscular injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intramuscular Transplantation of Autologous Muscle Derived Stem Cell(MDSC) and Adipose Derived Mesenchymal Stem Cells (AD-MSC) in Patients With Facioscapulohumeral Dystrophy (FSHD), Phase I Clinical Trial|
|Actual Study Start Date :||May 2014|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Stem cell recipient
The patients with FSHD who underwent muscle derived stem cell and Adipose derived mesenchymal stem cell with intramuscular injection.
Biological: Intramuscular injection
Intramuscular injection of stem cells in patients with FSHD.
Other Name: Intramuscular cell transplantation
- Myalsia [ Time Frame: 1month ]Evaluation the presence of myalsia 1month after cell injection.
- Mass formation [ Time Frame: 6 months ]Evaluation the probability of mass formation 6 months after cell injection.
- Hematoma [ Time Frame: 1 month ]Evaluation the presence of hematoma 1 month after injection.
- Muscle bulk [ Time Frame: 6 months ]Evaluation the muscle bulk changes with sonography and MRI 6 months after transplantation.
- CPK [ Time Frame: 1month ]Evaluation the decrease of CPK 1 month after cell transplantation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208713
|Contact: Nasser Aghdami, MD,PhD||(+98)23562000 ext email@example.com|
|Contact: Leila Arab, MD||(+98)23562000 ext 414||Leara91@gmail.com|
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Contact: Nasser Aghdami, MD,PhD (+98)212356000 ext 516 firstname.lastname@example.org|
|Contact: Leila Arab, MD (+98)23562000 ext 414 Leara91@gmail.com|
|Sub-Investigator: Neda Jarooghi, MSc|
|Sub-Investigator: Tina Bolourieh, BSc|
|Sub-Investigator: Fatemeh Abbasi, MSc|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||Nasser Aghdami, MD,PhD||Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute|
|Study Director:||Mahdi Vahid Dastjerdi, MD||Scientific Board of BouAli Hospital, Azad University|
|Principal Investigator:||Leila Arab, MD||Department of Regenerative Medicine & cell therapy of Royan Institute|