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Clinical Trials/CTRI/2011/091/000159
CTRI/2011/091/000159
Recruiting
Phase 2

A clinical trial to study the safety and efficacy of Bone marrow derived Autologous stem cells for the treatment of cerebral palsy in subjects above 15 years.

Chaitanya Stem Cell Center0 sites100 target enrollmentTBD
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ConditionsHealth Condition 1: null- Cerebral Palsy above 15 years

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: null- Cerebral Palsy above 15 years
Sponsor
Chaitanya Stem Cell Center
Enrollment
100
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Chaitanya Stem Cell Center

Eligibility Criteria

Inclusion Criteria

  • •1\. Should suffer from cerebral palsy due to prenatal and postnatal cause.
  • •2\. Willingness to undergoing Bone marrow derived 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

  • •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

Outcomes

Primary Outcomes

Not specified

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