To evaluate the safety and efficacy of R-HSC-001 in patients with Parkinsons Disease (Neurological disease)

Prospective open-labeled clinical study to evaluate the safety and efficacy of R-HSC-001 in patients with Parkinsons Disease.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000667

Enrollment

Registered

2009-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Parkinsons Disease

Interventions

Intervention1: R-HSC-001: One time bilateral injection in brain by steriotactic surgery Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female of between 35 to 75 years of age. 2. Patients with current diagnosis of PD. 3. Patients with at least 5 years since the disease. 4. Patient is able to comply with and understand the required visit schedule and required tests and procedures.

Exclusion criteria

Exclusion criteria: 1. History of intracranial surgery. 2. History of malignancy. 3. Contraindication of MRI. 4. Significant coagnitive impairement. 5. Any contraindication to surgery. 6. Abnormal hematology and biochemistry. 7. Positive test result of HBsAg, HCV and HIV. 8. Pregnant and lactating mother.

Design outcomes

Primary

Measure	Time frame
Change in UPDRS scoreTimepoint: Decrease in UPDRS score at 6 month post treatment	—

Secondary

Measure	Time frame
To assess the safety of R-HSC-001 in patients with Parkinsons DiseaseTimepoint: â?¢Treatment emergent adverse effects â?¢Improvement in Cognitive assessments â?¢Dyskinesia and Dystonia rating â?¢Quality of Life assessment. â?¢Decrease in the dose of L-dopa of Parkinsons disease	—

Countries

India

Contacts

Public ContactDr Chandra Viswanathan

Reliance Life Sciences Pvt. Ltd.

chandra.viswanathan@ril.com02240678352

Outcome results

None listed

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