Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury

Chinese Academy of Sciences

Status and phase: Unknown; Phase 1

Conditions: Brain Injury

Treatments: Procedure: Stereotactic Hematoma Evacuation; Biological: Injectable Collagen Scaffold with MSCs Transplantation; Biological: MSCs Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02767817

CAS-XDA-BI/IGDB

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain injury.

Enrollment: 30 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female，35-75 years old.
2. The surgery time should be > 6 hours after symptom onset.
3. Glasgow coma score (GCS) was 9-15.
4. CT diagnosis of intracerebral hemorrhage (25-40 ml), except for patients with signs of craniotomy to remove the hematoma.
5. Signed informed consent obtained from the patient or patient's legally authorized representative.

Exclusion criteria

1. Glasgow coma scale of <8.
2. Patients suffering severe heart failure, severe lung disease, uremia, cirrhosis, end-stage cancer, coagulation disorders, stroke sequela.
3. Asphyxia, cardiac arrest or successful cardiopulmonary resuscitation before hospitalization.
4. Lactating or pregnant woman.
5. Refuse to sign informed content.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Stereotactic Hematoma Evacuation

Sham Comparator group

Treatment:

Procedure: Stereotactic Hematoma Evacuation

MSCs Transplantation

Experimental group

Treatment:

Biological: MSCs Transplantation

Injectable Collagen Scaffold with MSCs Transplantation

Experimental group

Treatment:

Biological: Injectable Collagen Scaffold with MSCs Transplantation