Safety and Efficacy of BMMNCin Patients With Mental Retardation

Chaitanya Hospital, Pune

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Mental Retardation

Treatments: Biological: Intravenous transfer of BMMNC

Study type: Interventional

Funder types: Other

Identifiers

NCT01908400

CSCC/BMMR/2013//01

Details and patient eligibility

About

Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. There are many causes of mental retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells are used in this condition to prove its safety and efficacy .

Enrollment: 15 estimated patients

Sex: All

Ages: 5 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age limit: 5 -50
• Primary diagnosis of mental retardation (IQ < 70)
• willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) transplantation.
• To give an informed consent as well as sign the required Informed Consent Form (ICF)/video Consent for the study.
• 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

• Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
• Advanced age that may produce deteriorating cognitive or motor functioning
• Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
• Poor general health

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

BMMNCs

Other group

Description:

Intravenous transfer of (BMMNCs)

Treatment:

Biological: Intravenous transfer of BMMNC