Evaluation of the complications of injecting a combination of two types of muscle-derived and adipose-derived stem cells in patients with fascioscapulohumeral dystrophy

Safety of intramuscular co-injection of autologous muscle derived stem cell (MDSC) and allogenic adipose derived mesenchymal stem cell in patients with facioscapulohumeral dystrophy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20080728001031N25

Enrollment

Registered

2021-01-06

Start date

2014-03-21

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facioscapulohumeral dystrophy. Scapulohumeral muscular dystrophy

Interventions

Intervention group: Patients with fascioscapulohumoral dystrophy are hospitalized in Bu Ali Sina Hospital after preparing the cell suspension for injection. Cell suspension contains a combination of a

Eligibility

Sex/Gender

All

Age

15 Years to 50 Years

Inclusion criteria

Inclusion criteria: Facial muscles weakness including Frontalis, Orbicularis oculi, Orbicularis Oris Having the FSHD phenotype including involvement of the biceps and triceps muscles Confirmation of FSHD by genetic testing Age: 15-50 years old

Exclusion criteria

Exclusion criteria: Comorbidities such as heart and respiratory disease and diabetes Having a connective tissue or rheumatologic disease or a history of malignancy Inability to sign consent Advanced disease

Design outcomes

Primary

Measure	Time frame
Percentage of people with side effects including hematoma, myalgia and mass at the injection site, decreased level of consciousness, nausea and vomiting, headache, diplopia, urinary and fecal impairments, shortness of breath, increase or decrease in blood pressure. Timepoint: 24 hours after injection - 1 month after injection - 2 months after injection - 4 months after injection - 6 months after injection - 12 months after injection. Method of measurement: Clinical examination and the side-effects questionnaire.	—

Measure

Time frame

Percentage of people with side effects including hematoma, myalgia and mass at the injection site, decreased level of consciousness, nausea and vomiting, headache, diplopia, urinary and fecal impairments, shortness of breath, increase or decrease in blood pressure. Timepoint: 24 hours after injection - 1 month after injection - 2 months after injection - 4 months after injection - 6 months after injection - 12 months after injection. Method of measurement: Clinical examination and the side-effects questionnaire.

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Secondary

Measure	Time frame
Disease progression by measuring CPK. Timepoint: 24 hours after injection 1 month after injection 2 months after injection_ 4 months after injection_ 6 months after injection_ 12 months after injection. Method of measurement: Blood test.;Disease progression by measuring LDH. Timepoint: 24 hours after injection 1 month after injection 2 months after injection_ 4 months after injection_ 6 months after injection_ 12 months after injection. Method of measurement: Blood test.	—

Measure

Time frame

Disease progression by measuring CPK. Timepoint: 24 hours after injection 1 month after injection 2 months after injection_ 4 months after injection_ 6 months after injection_ 12 months after injection. Method of measurement: Blood test.;Disease progression by measuring LDH. Timepoint: 24 hours after injection 1 month after injection 2 months after injection_ 4 months after injection_ 6 months after injection_ 12 months after injection. Method of measurement: Blood test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasser Aghdami

Royan Institute

nasseragh@gmail.com+98 21 2251 8388

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026