Autologous Stem Cell Therapy in Patients With Multiple System Atrophy

Biocells Medical

Status and phase: Begins enrollment in 2 months; Phase 2

Conditions: MSA - Multiple System Atrophy; MSA

Treatments: Other: Placebo; Drug: MSCs

Study type: Interventional

Funder types: Industry

Identifiers

NCT07465198

Bio120004

Details and patient eligibility

About

This study investigates the safety and efficacy of autologous stem cell therapy in patients with Multiple System Atrophy (MSA), a rare and progressive neurodegenerative disorder characterized by autonomic failure, parkinsonism, and cerebellar ataxia. The trial will evaluate functional outcomes, motor performance, and quality of life compared to placebo/controlled group.

Enrollment: 50 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Multiple System Atrophy (MSA-P or MSA-C)
• Age range of 35 to 65 years

Exclusion criteria

• Other major neurological disorders
• Severe cardiac/renal/hepatic impairment
• Prior stem cell therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

MSC therapy

Experimental group

Description:

200,000,000 cells per infusion

Treatment:

Drug: MSCs

Saline Solution

Placebo Comparator group

Description:

0.9% saline infusion

Treatment:

Other: Placebo