A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of stroke.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/10/004105

Enrollment

100

Registered

2013-10-28

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- Stroke - Cerebral Hemiplegia

Interventions

Intervention1: Intra Thecal transplantation of Autologous Stem cells: 100 millions MNC per dose in 3 divided doses at interval of 10 days in stem cell therapy in total duration of 30 days Control Inte

Eligibility

Inclusion criteria

Inclusion criteria: 1.Should suffer from stroke due to cerebral infarct or haemorrhage or accelerated hyper tension. 2.Willingness to undergo Autologous Stem Cell Therapy 3.Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study. 4.Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion criteria

Exclusion criteria: 1.Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc. 2.History of life threatening allergic or immune-mediated reaction. 3. Haemodynamically unstable subjects. 4.Subjects suffering from peripheral muscular dystrophy. 5.Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure. 6.Positive test results for Hepatitis A and Hepatitis B or C. 7.Alcohol and / or drug abuse/ dependence. 8.Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL. 9.Neurological disease caused by autoimmune or genetic cause.

Design outcomes

Primary

Measure	Time frame
Improvement in power of Body and facial MusclesTimepoint: 3, 6, 9 months	—

Secondary

Measure	Time frame
Improvement In Walking Ability Improvement In Speech And Cognition. Improvement In Vision In Both Eyes.Timepoint: 3,6 & 9 Months	—

Countries

India

Contacts

Public ContactDr sachin jamadar

Chaitanya Hospital and NURSING HOME

anantbagul@yahoo.com08087799091

Outcome results

None listed

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